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Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

Accuray’s New TomoTherapy H Series of Radiation Oncology Devices

Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today launched its new TomoTherapy® H™ Series, featuring the TomoHDA™ System, with faster planning, faster delivery and increased quality. The TomoHDA System was unveiled at the 54th Annual American Society for Radiation Oncology (ASTRO) Meeting in Boston. Key features of the TomoHDA System include:

Accuray’s new TomoEDGE™ dynamic jaws technology provides users with added flexibility in treatment delivery by sharpening dose fall off and accuracy. In many cases the use of TomoEDGE for head and neck tumors and prostate cancer treatments has resulted in the reduction of beam-on time by half. With the TomoHDA™ System this new technology is standard and can be applied to both TomoHelical™ and TomoDirect™ treatment modes for 3DCRT and IMRT deliveries.

The high-performance VoLO™ Technology – an enhancement to the TomoTherapy® treatment planning system – leverages the new dose calculation algorithm and advanced graphics processing technology to increase clinical efficiency, throughput and flexibility in developing both simple and the most complex radiation therapy plans.

“We are committed to our TomoTherapy customers and continue to innovate to provide the most advanced treatments in radiation oncology with the goal of improving patient care,” said Joshua H. Levine, president and chief executive officer of Accuray. “The new TomoTherapy H™ Series offers treatment solutions for the entire spectrum of radiation therapy. It will enable unprecedented speed and efficiency ensuring the highest quality of care from the routine to the most complex cases.”

The TomoHDA System is a fully-integrated 3D image-guided, full spectrum radiation therapy system and builds upon the proven TomoTherapy Hi-Art® and TomoHD™ technologies. The TomoHDA System offers multiple new benefits including performance enhancements, unrivaled dose distributions and faster treatments.

The TomoHDA System is part of the new TomoTherapy H Series. Included in this series of products, is the new TomoH™ System, the gold standard for image-guided IMRT (intensity-modulated radiation therapy) treatment, providing streamlined 3D CT daily image guidance and ultrafast MLC (multileaf collimator) modulation, enabling the delivery of the dose to achieve excellent target homogeneity while sparing surrounding healthy tissue. Also included in the series is the TomoHD™ System – including TomoDirect – a full spectrum solution that provides high quality treatments to every patient for any clinical indication requiring radiotherapy.

The new TomoEDGE™ dynamic jaws are capable of sharpening the dose and allow customers to treat more patients with the TomoTherapy System. The jaws are optimized to sweep across the target, minimizing dose to healthy tissue and critical structures adjacent to the target and opening to the desired maximum size to reduce treatment time. The result is a balanced treatment delivery that is as unique as each patient.

Using the high-performance VoLO Technology, the TomoHDA™ system allows ultra fast creation of highly conformal treatment plans with the flexibility to design a personalized treatment plan specific to the individual needs of each patient. For example, the application of VoLO technology on breast cancer treatment plans has been shown to reduce dose calculation and treatment planning optimization time to as few as three minutes. TomoHDA also includes a fan-beam computed tomography (CT) system capable of producing images 50 percent faster, facilitating improved patient re-positioning time and therefore less overall time for the patient to be on the treatment couch.

“Having been involved in the creation of and research collaboration for the new TomoEDGE, we have seen firsthand that this is one of the most versatile radiation therapy treatment options available,” said PD Dr. Florian Sterzing, M.D., Consultant Radiation Oncologist at University Clinic of Heidelberg. “The new functionality enables improved quality of radiotherapy application and allows us to treat even more cancer patients.”

The TomoHDA System also includes Citrix®-based remote planning with web-based review capabilities, providing the ultimate flexibility for clinicians to develop and approve treatment plans from virtual workstations.

“TomoTherapy’s ability to treat the full range of disease sites, including even the most complex tumors, makes it an invaluable resource for cancer patients,” said Wade Gebara, M.D. Chief of Radiation Oncology at Berkshire Medical Center, Pittsfield, Mass. “With increased speed and reliability, the new TomoTherapy System will provide the opportunity for more patients to benefit from this personalized technology.”

Also on display in Accuray’s ASTRO booth (#7101) is the CyberKnife M6 FIM Sytem – part of the CyberKnife® M6™ Series – which is pending FDA 510(k) clearance and not yet available for commercial distribution in the United States. The new CyberKnife M6 FIM and FM Systems feature the InCise™ Multileaf Collimator, which combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery. The new InCise Multileaf Collimator (MLC) was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical precision into a broader field of applications. The system is intended to treat large and irregular tumors more efficiently with excellent dose gradients, to expand the number of patients eligible for treatment.

Researchers at Fox Chase Cancer Center in Philadelphia – who compared treatment plans created with a theoretical MLC on the CyberKnife System to those created originally with the CyberKnife Iris™ Collimator and conventional Intensity-Modulated Radiation Therapy (IMRT) plans – found that an MLC mounted on a robotic arm could potentially offer numerous clinical benefits, including faster treatment delivery, better target coverage and a sharper dose fall off could be achieved than a typical gantry- based IMRT plan or previous CyberKnife treatments. The Fox Chase researchers demonstrated the potential to create treatment plans that would spare critical structures around tumors better with a robotically mounted MLC, providing the ability to treat tumors using a higher dose without increasing the normal tissue toxicity.

Dates, times and locations of ASTRO clinical presentations featuring the CyberKnife and TomoTherapy Systems are available here.

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. To date 642 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expansion of the Company’s global presence, quality of treatments, accuracy, dose delivery, clinical efficiency, continual innovation, pending regulatory clearance, treatment times, dose sculpting, and the Company’s leadership position in radiation oncology innovation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading “Risk Factors” in the company’s report on Form 10-K filed on September 10, 2012. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not place undue reliance on any forward-looking statements.

The TomoTherapy® System, the premier solution for the entire spectrum of radiation therapy — that delivers dose only where you need it — now with outstanding speed, performance and simplicity — allowing you the freedom to choose the very best treatment for each of your patients, with confidence and without compromise.

Created to make personalized treatments an option for radiation therapy, the TomoTherapy H Series offers interactive planning and efficient delivery of highly sculpted doses for personalized and consistent treatments. Seamless daily CT image guidance provides precise patient positioning, margin reduction and adaptive planning and enables pinpoint dose accuracy for every radiation therapy patient.

Accuray launched its new TomoTherapy H Series line of radiation oncology devices, headlined by the 3D image guided TomoHDA System with TomoEDGE technology. TomoEDGE optimizes radiation delivery by sharpening the affected edge between the target tumor and healthy tissue.

Accuray TomoTherapy H Series table Accurays New TomoTherapy H Series of Radiation Oncology Devices (VIDEO)

The company’s VoLO technology takes into account the new radiation dose delivery pattern into its calculations when doing graphic analysis in preparing treatment plans.

The three devices in the TomoTherapy H Series:

The TomoHDA™ System – the ultimate flexibility in treatment delivery with unrivaled dose conformality, faster patient treatments, and faster concurrent treatment planning. It grants everypatient access to high quality treatment

TomoEDGE™ spares more normal tissue while enabling increased throughput —with unprecedented quality

High performance VoLO™ planning provides flexibility, speed, efficiency and interactivity for concurrent treatment planning

Expand your practice by efficiently treating patients that are difficult to treat with conventional radiation therapy equipment

The TomoHD™ System- the full spectrum solution for any Radiation Oncology center, providing high quality treatments to every patient for any clinical indication requiring radiotherapy

TomoHelical™ and TomoDirect™ modalities to enable delivery of individualized treatments for both routine and complex indications

VoLO planning provides the ultimate in flexibility, speed and efficiency with real time interactive planning

The clinical solution when accuracy, flexibility and efficiency cannot be compromised

The TomoH™ System- the gold standard for image guided IMRT treatment delivery maximizes both conformality and target dose uniformity

CTrue™ image guidance provides daily 3D CT target localization and enables margin reduction while sparing healthy tissue

Ultra-fast binary MLC enables unprecedented intensity modulation

Excellent target homogeneity while sparing more normal healthy tissue

Source : http://www.accuray.com/media/press-releases/accuray-launches-new-tomotherapy%C2%AE-h%E2%84%A2-series-featuring-tomoedge%E2%84%A2

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How a Lawyer Approaches the Problems of Physicians, Scientists, and Engineers: Exclusive with Attorney Anthony Wicht

How a Lawyer Approaches the Problems of Physicians, Scientists, and Engineers: Exclusive with Attorney Anthony Wicht

How a Lawyer Approaches the Problems of Physicians, Scientists, and Engineers: Exclusive with Attorney Anthony Wicht

Medgadget editor Dan Buckland is in training to become a physician while trying to remain an engineer. Here he talks about how his training in different thinking styles leads to different problem solving strategies.

In my last post, I mentioned that I thought that a lot of the miscommunications between Surgeons and Engineers were due to the differing ways that they approach problems. More than a personality difference, Physicians [1] and Engineers are trained with different philosophies of problem solving. Scientists are another group that is often mentioned in the same breath as Physicians and Engineers, and they are trained in a third, different way as well [2]. With this article I’ll explore these differences, and also discuss three example problems that characterize these three different ways of thinking. These three types of problem solvers (Scientist, Engineer, Physician) are meant as archetypes representing the training methods each field is known for. Of course, an individual would use a mix of these problem solving methods based on their knowledge and experience, but they may never have received formal training in methods other than the ones they are expert in. These simplistic descriptions are not meant to imply that all people in each of the described groups are only one way or that they are incapable of seeing things another way. (For more caveats please also see my footnotes at the end.)

divider How Physicians, Engineers, and Scientists Approach Problems Differently The 3 Types:

The Physician: MDs are trained in medical school to think about differentials and categories. A patient’s presenting signs and symptoms are processed, then historical information is used to determine the most common diagnosis associated with that data set. More complicated tests are given based on the most common and most dangerous diagnoses, and then treatment is often based on the outcomes of those tests. This is a categorical approach to problem solving. The MD tries to determine what category the patient belongs in, and then treatment is based on the assigned category. This is a very efficient system when a patient has a problem that has been encountered before and a pre-existing data-set that the patient can be matched too. Often, a complete picture isn’t even needed since this problem solving approach is based on probabilities. However, when the patient has something not seen before, this is a very inefficient way of treating the problem, as the MD moves to less and less common solutions. Programmers would call this searching a known set, which is often the fastest way to find a solution if the solution is in the set, but it is the slowest if the solution is not, as all possibilities have to be excluded before determining that the answer isn’t there.

The Scientist: In contrast to the MD, the Scientist is trained to look at a problem in the abstract and use testable hypotheses to isolate all the component parts of a problem and solve them (individually, if possible) in a logical way [3]. Breaking down the problem into its component parts can determine the independent root causes. Then, using those root causes, the Scientist can arrive at a solution to the overall problem. Solving problems in this way is more resource- and time-intensive than the Physician method, but if the right hypotheses are posed, this system can handle a broader range of problems and generate new data that are applicable to other problems. Programmers would call this a global search, which is often the least efficient way to find a solution, but the solution found would have a higher chance of being the optimal solution because it ideally takes into account the most information [4].

The Engineer: One way to think of the Engineer’s method is as a hybrid of the Scientist’s and Physician’s methods. The Scientist starts with a new set of hypotheses for each problem, and the Physician starts with a set of solutions that can be applied. The Engineer is trained to take a known solution and then use that as a starting point to hypothesize a solution that applies to the problem. Thus, the Engineer’s approach is also a combination of the advantages and disadvantages of the above methods. Like the Scientist, the Engineer tries to break down the problem, but doesn’t break it down all the way. Since the Engineer isn’t looking for a root cause, the problem is only simplified enough to get a solution that works with the least amount of change from the current paradigm. Going back to our programming analogy, this is a local search: again, a hybrid of the two above examples.

divider How Physicians, Engineers, and Scientists Approach Problems Differently

Three Approaches to Three Problems:

In this section, I will lay out a problem and describe how the three archetypes above would approach solving the problem. These are not random problems, each one is meant to show that none of the problem solving types is inherently better than the others, but that they are each better suited to different situations.

Patient A started coughing this morning, what should she do about it?

Physician: What are the top 5 reasons people cough? Has she been treated successfully for a cough in the past? For this patient’s age and medical history, which of those 5 causes are most likely? Would any test results change the treatment plan? Treatment will be based on what has historically worked best for the most likely diagnosis.

Scientist: What would cause this patient’s particular cough? What is the root cause of her lung or throat irritation? If it is infectious, what is causing the infection? If we find what is causing the infection, do we know how it is causing the cough or irritation?

Engineer: What is different now than when she wasn’t coughing? What was she doing this morning when the cough started? If she tries one treatment and gets a little better, then she should use more of it to get a greater effect.

In this case, the Physician probably has the fastest and most efficient route to diagnosis and treatment plan if there is a common cause for the cough. The Scientist’s method, when it eventually gets to a treatment, will have produced a lot of information, but it will take a longer time and be very resource intensive. However, if there is a uncommon cause for the cough, the Scientist method will be more likely to find it. The Engineer’s method could work as well, but doesn’t use the shortcuts of the Physician or the robust strategy of the Scientist.

Patients B,C, D, E, and F all have a form of slow growing cancer no one has seen before. They are all related, but the inheritance pattern is not one that has been observed in other cancers. What should be done?

Physician: Of all the cancer types known, which one is the closest to this one? How is that cancer treated? If that doesn’t work, what is the next closest match? How is that one treated?

Scientist: How does this cancer work? What is the cell type involved? What makes the cancerous versions of that cell type different than the non-cancerous versions? Is that difference something that can be detected in this patient? Can that information be used to determine how to kill just the rapidly growing version of that cell type and leave the rest alone?

Engineer: What makes this cancer different than the closest match that has been treated in the past? Can we use that difference to modify the treatment plan?

In this case the Scientist’s method is probably the best approach to take, since the problem itself has very little known about it. The Physician method will get to a treatment quicker, but is likely a shot in the dark and may cause more pain and discomfort with less overall benefit if the closest guess has a very different root cause. The Engineer method looks at these differences to try to get to a solution.

Patient G had her gallbladder removed by Dr. H. Dr. Hn performs the procedure laparoscopically, but the tools she uses don’t work the way she wants them to, and she feels that she spends too much time struggling with the equipment rather than doing the procedure. Other surgeons say they have the same problem too. What should be done?

Physician: What have other surgeons done to compensate for the unwieldy tools? Do any of those methods fix the problem of taking too much time struggling with equipment?

Scientist: How would we design a brand new laparoscopic system that doesn’t have those problems?

Engineer: What exactly does the surgeon like and dislike about the system. How could we modify the current system to keep the benefits and lose the difficulties?

For this issue the Engineer probably has the best approach. Rather than starting from scratch like the Scientist, or treating the problem as fixed like the Physician, the Engineer’s approach looks for the simplest novel solution using the current context. divider How Physicians, Engineers, and Scientists Approach Problems Differently

Conclusions:

A better understanding of the problem solving methods of others can go a long way in improving communication. A common response on Twitter to my last article was that a lot of communication problems could be solved by just putting everyone in the same room together. While that might work, anyone who has gone through MBTI training of some sort knows that is really just a new way to start conflict unless there exists an understanding that the other people in the room don’t think and respond the same way as you. The three archetypes detailed in this post don’t break down neatly within the MBTI categories, though some similarities exist. In a future post I will discuss other ideas for improving communication between these groups

While this simple breakdown leaves a lot to be detailed, hopefully it is a step in the right direction that allows people from different fields to work together more efficiently.

divider How Physicians, Engineers, and Scientists Approach Problems Differently

Footnotes:

[1] For the purposes of this post I am grouping Surgeons and Physicians into a single group. All MDs went through the same 4 years of medical school (at least in the US) and as different as the two groups see themselves, their training is more similar to each other than to the other two groups.

[2] If you were wondering, I don’t know where Management and Administrative types would fit on this spectrum. I suspect they would be a whole separate category when it comes to problem solving, based on my interactions with them. Unfortunately I don’t have enough experience with the training they go through to develop an informed description and I am similarly uninformed about Sales types.

[3] This is the same scientific method learned in middle school. Your teacher wasn’t wrong about how this stuff would be useful later in life.

[4] The reader may note that the author’s expertise is in the training of engineers and physicians, so where does he get his info about scientists? He is married to a very good one, and she helped him out with this part.

Medgadget editor Dan Buckland is in training to become a physician while trying to remain an engineer. Here he interviews a person cross-trained in Law and Engineering to get a broader perspective on how education in different thinking styles leads to different problem solving strategies.

In my previous articles about the problem solving skills of Physicians, Scientists, and Engineers I was not able to address some of the other professions that are clearly involved in the Med Tech industry, mostly due to my lack of knowledge and training in these other fields. Lawyers are involved in both successful and unsuccessful medical technology projects, with a lot of frustration arising from the lack of knowledge by non-Lawyers about the legal world. Even apart from the differing experiences of people involved I think some of this lack of understanding comes from the very different ways each group was trained to solve problems and even how each group formulates problems themselves. As you can see from the interview below with Anthony Wicht, Lawyers start from a very different place than the other professions we have discussed so far. Mr. Wicht is a former lawyer and engineer who now works on policy for the Australian Government. He holds degrees in Law and Civil Engineering from the University of New South Wales in Australia, and a Masters of Science in Aerospace engineering from MIT in the United States. Via email I asked Mr. Wicht about the cases from my problem solving article and his thoughts on the differences between Physicians’, Scientists’, Lawyers’ and Engineers’ approaches to problem solving. The previous caveats about discussing these diverse professions as homogeneous groups still apply.

1) Patient A started coughing this morning, what should she do about it?

Anthony Wicht How a Lawyer Approaches the Problems of Physicians, Scientists, and Engineers: Exclusive with Attorney Anthony WichtA lawyer would instantly think about responsibilities for action. As a start, a lawyer would recognize the danger of advising Patient A as to what she should do without being properly qualified to do so.

After a moment’s reflection, however, legal methods of thinking suggest possible courses of action. A lawyer is likely to look to rules as to how to behave in this situation. Are there workplace policies at Patient A’s workplace which guide whether she should or shouldn’t come into work? And how do the consequences of breaching these actions compare to Patient A’s preferences to go to work or stay home? Perhaps there is a precedent, by which lawyers mean known previous outcomes which suggest answers. If Patient A visited the physician last time she had a cough and was told “you did well to come and see me because as an asthmatic you are susceptible to complications”, then seeing a physician is indicated by precedent.

On a third layer, a legal analysis would look for desired outcomes. Does Patient A want to find a way to stay at home, in which case finding a friendly physician to excuse her from work becomes the priority? Or does Patient A want to work so she gets paid, perhaps in spite of company policy which says she should stay home, in which case finding a cough suppressant is more important.

2) Patients B,C, D, E, and F all have a form of slow growing cancer no one has seen before. They are all related, but the inheritance pattern is not one that has been observed in other cancers. What should be done?

A cynical analyst would suggest that a lawyer would look to allocate blame in this case. What is the cause of the cancer, and can someone be sued because of it? Perhaps a class action can be mounted on behalf of all of the patients. On the face of the matter this is an attractive way of thinking for the patients, because the financial windfall may cover the patients’ cost of treatment.

In truth, though, a good lawyer looks beyond the allocation of blame to a broader idea of ‘society’s rules’. Arrangements from health insurance to the writing of a will to the obligations of their employers are affected by their illness. In parallel with the treatment process, these aspects of the patients’ lives may make the difference between a recovery to a life very like the one they had previously, and a recovery beset by worries of debt and eventual poverty.

You will notice that the legal analysis does not touch the patient’s treatment, a matter of science. The lawyer knows that that is not their place. The lawyer immediately thinks of the social context of the patient’s illness, and about whether benefits, under the rules that govern the interaction between the person and society, have been triggered as a result of the illness.

3) Patient G had her gallbladder removed by Dr. H. Dr. H performs the procedure laparoscopically, but the tools she uses don’t work the way she wants them to, and she feels that she spends too much time struggling with the equipment rather than doing the procedure. Other surgeons say they have the same problem too. What should be done?

This problem can be approached from two angles. The obvious one is from the perspective of Dr. H and her colleagues, who want equipment which works better. What did the manufacturer promise to deliver? Under those agreed rules (‘contract’), can the manufacturer be made to improve the product? Or is Dr. H’s machine faulty (and her colleagues clumsy), in which case the manufacturer could be forced to replace it?

Assuming the manufacturer is not in breach of contract, lawyers can still help their clients. Many lawyers will try and facilitate mutually satisfactory agreements even when there is no compulsion for the parties to act by law. A win-win situation here might be to have Dr. H and her colleagues become a focus group for the manufacturer, trialling and critiquing new equipment so that it works better for them and so the manufacturer can sell more units.

The second angle is the perspective of Patient G. Did they get the standard of care they were reasonably entitled to? If not, was Dr H at fault for performing the procedure with tools she knew were below par? Or is the manufacturer at fault? Is the patient prepared to endure the stress of litigation for the potential payout of a successful lawsuit?

4) What is a stereotypical law school problem, and how do you solve it?

I was taught the answer to every law school problem on my first day in law school: ‘it depends’. My professor was very clear about that. And it applies to many real world law problems as well.

A law school problem is solved (in general) in the following way.

Identify (or agree on) the facts which give rise to the problem

Identify any legislation or previous judgments (‘case law’) which dealt with a similar fact situation

Apply the legislation or the case law to the facts in this case. Is it clear that the legislation applies, or is it arguable? Were there differences between the facts in the previous judgement which made the case law and the facts now?

Draw a conclusion, and say how strongly that conclusion can be supported. For example, it is likely that the defendant would be found guilty.

After law school the only difference is that the order in which the questions are answered usually starts with 4 (the preferred conclusion) and moves in reverse order thought the steps, searching for ways to support that conclusion.

Invariably, in law school, the application of the law to the facts is not straightforward – hence, it depends. The fact situations are usually a laughably improbable compilation of the facts underlying the key cases taught through the semester, with slight variations to make the application of the law to the facts not straightforward.

For example, if the semester had included a case about environmental pollution by a factory pumping chlorine into a creek, the fact situation may include a caveat where a factory thought they were pumping chlorine into a creek but in fact, due to a mistake by the construction company, were pumping water. Do the facts of the original case still apply? Why or why not?

This approach places a premium on really understanding the cases, rather than simply remembering them. In fact most law schools run open book or take-home exams to emphasize understanding over memorization.

5) As someone who is trained in both the JD and engineering way of thinking, what do individuals only trained in one way not know about the thinking process of the other? Are there any words/phrases/concepts that have differing meaning in both fields?

Law is fundamentally different to engineering, science and medicine in one important way. Law is completely a human construct. In engineering, science and medicine, as Richard Feynman famously said, “nature cannot be fooled” (1). Bridges fall down, chemicals react, and people become sick according to physical processes irrespective of human preferences, agreements or desires. In law, human perspective is everything. People make laws, interpret laws and enforce laws, and if there is total agreement to act contrary to a law, then the text of the law is irrelevant. Laws are different from state to state and country to country. Physics is invariant.

This difference means that lawyers put a premium on being convincing (as opposed to being right). The engineer, on the other hand, puts being right well ahead of being convincing (2). Is it any wonder then that both lawyers and engineers can’t believe the other “doesn’t understand the real world”. In a way, both are right.

Source : http://history.nasa.gov/rogersrep/v2appf.htm

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Bacteria-Based Strips for Blood Glucose Monitoring

Bacteria-Based Strips for Blood Glucose Monitoring

Bacteria-Based Strips for Blood Glucose Monitoring

People with diabetes may one day have a less expensive resource for monitoring their blood glucose levels, if research by a group of Missouri University of Science and Technology students becomes reality.

Members of the Missouri S&T chapter of iGEM – the International Genetically Engineered Machine Foundation – recently devised a biological system that uses segments of DNA embedded in bacteria to detect glucose. The students believe their development could lead to a new type of test strip for diabetics.

IGEM-2011-web450.jpg

Biological sciences students Erica Shannon, left, and Amanda Foster are among the members of Missouri S&T’s iGEM chapter. The group developed a biological system to detect glucose levels, a process that could one day help people with diabetes.

“We designed DNA so that bacteria that have DNA would sense a change in osmolarity due to the presence of glucose,” says Erica Shannon of Wildwood, Mo., a senior in biological sciences at Missouri S&T and president of the campus’s iGEM chapter. Osmolarity refers to the concentration of a compound – in this case, glucose – in a solution.

For their project, the students designed genes that allow the bacteria – a non-virulent strain of E. coli – to sense the presence of the simple sugar glucose. The bacteria emit a yellow glow when glucose is present. As glucose concentrations become higher, the glow becomes brighter.

The team developed the system as part of an annual competition sponsored by iGEM, the Americas Regional Jamboree, held Oct. 8-10, 2011, in Indianapolis. S&T’s iGEM chapter received a silver medal for their effort.

According to Shannon, her team’s biological system could form the basis for new, less costly processes to help people with diabetes monitor their blood-sugar levels. It would require replacing the fluorescent gene with one that would cause the bacteria to change color based on glucose levels. This in turn could lead to the development of diabetes blood-test strips that could indicate glucose levels based on various colors. For example, a test strip might turn green if glucose levels are within normal ranges, yellow if borderline and red if elevated.

“All you would have to do is put the DNA inside a bacteria and you’ve got your test strip,” says Shannon.

Bacteria-based test strips would also be less expensive to make than current chemical-based test strips, Shannon says.

“In the future, based on further research, an insulin gene could be added to this system for use in insulin pumps, where specific glucose levels trigger insulin production,” she says.

In addition to Shannon, other members of the iGEM team include:

Amanda Foster of Jefferson City, Mo, a senior in biological sciences and biochemical engineering and chapter vice president.

Blythe Ferriere of Sturgeon, Mo, a junior in chemical engineering and chapter treasurer.

Brice Curtin of St. Louis, Mo, a senior in chemistry and chapter secretary.

Lou Harmon of St. Louis, Mo, a senior in computer science and chapter webmaster.

David Pohlman of Arnold, Mo, a junior in biochemical engineering and chapter lab manager.

Alie Abele of Long Lane, Mo, a sophomore in environmental engineering.

Erica McFarland of Rolla, Mo, a senior in biological sciences.

Hannah Frye of Lee’s Summit, Mo., a biochemistry major.

Beth Wilkins of Rolla, Mo, a junior in biological sciences and chemistry.

Emily Puleo of St. Louis, Mo, a freshman in biochemistry.

Logan Sauerbrei of Lebanon, Mo, a junior in biological sciences.

Chester Gregg of Maryville, Mo, a junior in computer science and physics.

Amber Kreps of St. James, Mo, a senior in biological sciences.

Christy Kwon of Rolla, Mo, a student at Truman State University in Kirksville, Mo.

Gavin Pringle of Cape Girardeau, Mo, a sophomore in computer science.

Tyler Robinson of St. Louis, Mo, a senior in biological sciences.

Thomas Congdon of St. Robert, Mo, a freshman in biological sciences.

The team advisors are Dr. David Westenberg and Dr. Katie Shannon, both associate professors of biological sciences at Missouri S&T.

Normally you wouldn’t want your test strips to get into contact with bacteria; you’d want to store the strips in a safe and clean place. But what if the bacteria were part of the test strip? Students from Missouri Science and Technology have made a system in which they use segments of DNA embedded in bacteria to detect glucose.

The students have used a non-virulent strain of E.coli and put designed genes into the bacteria’s DNA, enabling them to sense the presence of glucose. The bacteria emit a yellow glow if there is glucose and as the glucose concentration rises, the glow becomes brighter. The DNA senses a change in osmolarity due to the presence of glucose.

It could become the basis for a new way to monitor blood glucose levels. The plan is to replace the fluorescent gene with another gene, which would make the bacteria change color based on glucose concentrations. Bacteria based test strips might also be less expensive than chemical based strips, which are currently used. A future step in the development of this system, is to add an insulin gene for use in insulin pumps, where certain glucose levels trigger insulin production.

Source : http://news.mst.edu/2012/01/student_teams_glucose_sensor_u.html

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LGTmedical’s Vital Signs DSP Uses Any Smart Device as Medical Sensor Interface

LGTmedical’s Vital Signs DSP Uses Any Smart Device as Medical Sensor Interface

LGTmedical’s Vital Signs DSP Uses Any Smart Device as Medical Sensor Interface

The greatest challenges facing the mHealth industry relate to creating relevant, low cost, cross platform products. LionsGate Technologies (LGTmedical) has solved these challenges for mobile vital signs monitoring. Through the development of a universal, audio-based interfacing framework, known as the Vital Signs DSP™, ultra-low cost, mobile vital signs monitoring has been achieved, connecting standard medical sensors with any mobile device. This first-of-its-kind, audio-based interface will make vital signs monitoring available to healthcare workers and consumers for a fraction of the price of current devices.

http://www.youtube.com/watch?v=HTi9cnEVTCQ&feature=player_embedded

The company’s flagship product, the Phone Oximeter™, leverages the global ubiquity of mobile phones to provide non-invasive measurements of blood oxygen levels and heart rate. Initially prototyped in 2010, the Phone Oximeter™ is accurate, robust, portable and powered by the mobile device.

LionsGate Technologies of Vancouver, Canada has announced a new technology offering that provides the ability for all sorts of medical sensors to easily use smartphones and tablets as their interface. By using the audio jack as the cheap and universal way to transfer data, LionsGate can make their technology compatible with just about any programmable consumer device out there.

They’ve already demonstrated their Vital Signs DSP technology by building a pulse oximeter that works straight off an iPhone’s audio jack and displays readings on its screen. This technology gives companies the ability to focus on the core technology they’re working on, either during development or for actual production of a cheap medical device that doesn’t need its own display.

Source : http://lgtmedical.com/

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Patients, physicians face health IT divide

Patients, physicians face health IT divide

When it comes to consumer use of health information technology, demand seems to be outstripping supply and it’s creating a great healthcare chasm. Results of a new survey show that, while three out of four patients are eager to access health records online through EMRs and more than 60 percent want to communicate with their doctor via email or other Internet technology, only 40 percent of physicians said they had the capability to interact with patients through email or give them access to their online health records. This despite the fact that 70 percent of surveyed physicians said they had basic electronic medical records capability within their organizations (Parmar, 9/27).

http://www.kaiserhealthnews.orgThis article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Source : http://www.news-medical.net/news/20120929/Patients-physicians-face-health-IT-divide.aspx

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Portable Device to Diagnose Malaria – Down to Specific Mutations

Portable Device to Diagnose Malaria – Down to Specific Mutations

Portable Device to Diagnose Malaria – Down to Specific Mutations

A pioneering mobile device using cutting-edge nanotechnology to rapidly detect malaria infection and drug resistance could revolutionise how the disease is diagnosed and treated.

Around 800,000 people die from malaria each year after being bitten by mosquitoes infected with malaria parasites. Signs that the parasite is developing resistance to the most powerful anti-malarial drugs in south-east Asia and sub-Saharan Africa mean scientists are working to prevent the drugs becoming ineffective.

The €5.2million (£4million) Nanomal project – launched today – is planning to provide an affordable hand-held diagnostic device to swiftly detect malaria infection and parasites’ drug resistance. It will allow healthcare workers in remote rural areas to deliver effective drug treatments to counter resistance more quickly, potentially saving lives.

The device – the size and shape of a mobile phone – will use a range of latest proven nanotechnologies to rapidly analyse the parasite DNA from a blood sample. It will then provide a malaria diagnosis and comprehensive screening for drug susceptibility in less than 20 minutes, while the patient waits. With immediately available information about the species of parasite and its potential for drug resistance, a course of treatment personally tailored to counter resistance can be given.

Currently for malaria diagnosis, blood samples are sent to a central referral laboratory for drug resistance analysis, requiring time as well as specialised and expensive tests by skilled scientists. Additionally, confirmation of malaria is often not available where patients present with fever. Very often, drug treatments are prescribed before the diagnosis and drug resistance are confirmed, and may not be effective. Being able to treat effectively and immediately will prevent severe illness and save lives.

The Nanomal consortium is being led by St George’s, University of London, which is working with UK handheld diagnostics and DNA sequencing specialist QuantuMDx Group and teams at the University of Tuebingen in Germany and the Karolinska Institute in Sweden. It was set up in response to increasing signs that the malaria parasite is mutating to resist the most powerful class of anti-malaria drugs, artemisinins. The European Commission has awarded €4million (£3.1million) to the project.

Nanomal lead Professor Sanjeev Krishna, from St George’s, said: “Recent research suggests there’s a real danger that artemisinins could eventually become obsolete, in the same way as other anti-malarials. New drug treatments take many years to develop, so the quickest and cheapest alternative is to optimise the use of current drugs. The huge advances in technology are now giving us a tremendous opportunity to do that and to avoid people falling seriously ill or dying unnecessarily.”

QuantuMDx’s CEO Elaine Warburton said: “Placing a full malaria screen with drug resistance status in the palm of a health professional’s hand will allow instant prescribing of the most effective anti-malaria medication for that patient. Nanomal’s rapid, low-cost test will further support the global health challenge to eradicate malaria.”

The handheld device will take a finger prick of blood, extract the malarial DNA and then detect and sequence the specific mutations linked to drug resistance, using a nanowire biosensor. The chip electrically detects the DNA sequences and converts them directly into binary code, the universal language of computers. The binary code can then be readily analysed and even shared, via wireless or mobile networks, with scientists for real-time monitoring of disease patterns.

The device should provide the same quality of result as a referral laboratory, at a fraction of the time and cost. Each device could cost about the price of a smart phone initially, but may be issued for free in developing countries. A single-test cartridge will be around €13 (£10) initially, but the aim is to reduce this cost to ensure affordability in resource-limited settings.

In addition to improving immediate patient outcomes, the project will allow the researchers to build a better picture of levels of drug resistance in stricken areas. It will also give them information on population impacts of anti-malarial interventions.

Clinical trials of the device are expected to begin within three years, after which it will be brought to market. The technology could be adapted afterwards for use with other infectious diseases.

Nanomal is developing a low cost device to address a real market need for full malaria diagnosis from sample to result in under 15 minutes at the patient’s side. We’re taking complex DNA analysis and simplifying it for use by health workers from all types of backgrounds and healthcare environments. By integrating diagnostics with cell phone technology we’re also able to support health workers in not only diagnosing and prescribing the right anti-malarial but also to support educating their patients at the time of consultation and remotely in their homes and at work.

OUR TECHNOLOGIES

DNA Extraction and PCR

DNA extraction

QuantuMDx has created a simple solution for on-chip DNA extraction and PCR that is capable of performing the lysis and extraction of malaria DNA from a pinprick of blood and then amplifying up the malaria DNA regions of interest, via an on-chip thermal cycler, ready for detection. This process, which normally takes a number of hours in a regular laboratory, takes minutes with Nanomal technology.

Diagnostic biosensor

Diagnostic Biosensor

QuantuMDx’s novel nanowire based biosensor detects the binding of the regions of malaria DNA of interest to probes immobilized on the surface of the array of nanowires. This detection is based upon the DNA’s innate electrical charge which means there’s no fluorescence, no optics and no light. This allows Nanomal to miniaturise the processes of a complex laboratory into a handheld which will be the first time this has been achieved. The biosensor then converts the electrical signal straight into binary code, the universal language of computers. As we use standard CMOS produced computer chips, the Consortium is able to bring down the cost of complex malaria diagnostics into the low price point of routine pathology testing and, moreover, deliver this testing at the patient’s side.

Genomic sequencing biosensor

Thermal Reactor

Nanomal will also be using QuantuMDx’s proprietary genomic sequencing biosensor to sequence areas of the malaria genome conferring drug resistance. The nanowires within the genomic sequencer have been arrayed and functionalized for long reads lengths as well as undertaking shotgun sequencing, vital for clinical utility and identifying emerging drug resistance in real time.

Malaria Assay

St George’s will be developing a far-reaching malaria assay to port onto the diagnostic platform which not only detects the malaria species but a wide range of genetic mutations which confer drug resistance within the malaria parasite. This definitive assay coupled with on-chip sequencing of parts of the malaria genome will provide the most comprehensive test ever for malaria diagnosis

QuantuMDx’s Q-POC™ point of care device is in development and will shortly deliver affordable, rapid and accurate medical diagnosis in less than 20 minutes, with the same accuracy (sensitivity and specificity) as any state of the art full laboratory, at the patient’s side, but at a fraction of the cost. Disposable diagnostic cartridges for companion diagnostics, TB, sexually transmitted diseases, genetic testing and cardiovascular disease are in development with our partners.

Q-POC™ is being developed for both developed and developing nations such as India, Africa and Brazil where there is a need for cheap POC testing that can be undertaken by health professionals or technicians in rural areas.

Researchers at St George’s, University of London today announced they’re leading a new project, called Nanomal, to develop a portable device that can detect the malarial parasite and identify its species within 15 minutes. malaria detector 2 Portable Device to Diagnose Malaria Down to Specific MutationsThe work is being conducted along with QuantuMDx Group, a diagnostics and DNA sequencing firm, and researchers from the University of Tuebingen in Germany and the Karolinska Institute in Sweden.

The press release says that the device is “the size and shape of a mobile phone,” and does bear a striking resemblance to the new iPhone 5. It features QuantuMDx’s extraction and PCR technology, a biosensor that etects the binding of the regions of malaria DNA of interest to probes immobilized on the surface of the array of nanowires,” and the company’s own genomic sequencing biosensor. St. George’s is developing a malaria assay that will run on the device and will be able to help identify genetic mutations that relate to a strain’s drug resistance.

From St. George’s:

Nanomal lead Professor Sanjeev Krishna, from St George’s, said: “Recent research suggests there’s a real danger that artemisinins could eventually become obsolete, in the same way as other anti-malarials. New drug treatments take many years to develop, so the quickest and cheapest alternative is to optimise the use of current drugs. The huge advances in technology are now giving us a tremendous opportunity to do that and to avoid people falling seriously ill or dying unnecessarily.”

The handheld device will take a finger prick of blood, extract the malarial DNA and then detect and sequence the specific mutations linked to drug resistance, using a nanowire biosensor. The chip electrically detects the DNA sequences and converts them directly into binary code, the universal language of computers. The binary code can then be readily analysed and even shared, via wireless or mobile networks, with scientists for real-time monitoring of disease patterns.

The device should provide the same quality of result as a referral laboratory, at a fraction of the time and cost. Each device could cost about the price of a smart phone initially, but may be issued for free in developing countries. A single-test cartridge will be around €13 (£10) initially, but the aim is to reduce this cost to ensure affordability in resource-limited settings.

In addition to improving immediate patient outcomes, the project will allow the researchers to build a better picture of levels of drug resistance in stricken areas. It will also give them information on population impacts of anti-malarial interventions.

Source : http://www.sgul.ac.uk/media/latest-news/nanotechnology-device-aims-to-prevent-malaria-deaths-through-rapid-diagnosis

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Masimo’s Oximeters and Neonatal Sensors for Critical Congenital Heart Disease (CCHD) Screening

Masimo’s Oximeters and Neonatal Sensors for Critical Congenital Heart Disease (CCHD) Screening

Masimo’s Oximeters and Neonatal Sensors for Critical Congenital Heart Disease (CCHD) Screening

Radical is the most advanced, yet flexible pulse oximeter in the world. In addition to being the most feature-packed, stand-alone pulse oximeter available, Radical can operate in two additional modes. The front module of Radical can be removed, creating a fully featured handheld pulse oximeter, ideal for transport. Radical can also be used to upgrade existing equipment through the sensor connector, thus not requiring additinal hardware or software upgrades to improve the performance of your current multiparameter monitor to Masimo SET.

Masimo SET is the proven gold standard in reading through motion & low perfusion to reduce false alarms and detect true eventsThe Radical is a fully featured Standalone pulse oximeter

The Radical is a fully featured Handheld pulse oximeter

The Radical interfaces to validated multiparameter patient monitors to replace the existing conventional pulse oximetry with Masimo SET pulse oximetry.

Unprecedented specificity and sensitivity. Essentially eliminates false alarms and detects virtually all true alarms.

Accurate during most patient movement, including shivering, combativeness, neonatal movement, and seizures. Motion and Low Perfusion Study

Accurate during low perfusion.

Accurate during intense ambient light and resists electrocautery interference.

The Radical is now “Rainbow®-Ready”. To learn more, click here.

For a list of validated monitors? click here.

Masimo has announced that the firm’s Signal Extraction Technology (SET) pulse oximeters, rainbow SET Pulse CO-Oximeters, and neonatal sensors have been cleared by the FDA for use in screening newborns for critical congenital heart disease (CCHD).

This helps address a big, new need as a year ago, the U.S. Department of Health and Human Services added pulse oximetry screening of newborns for CCHD to the Recommended Uniform Screening Panel.

Some study results that led to the new clearance:

Dr. Anne de-Wahl Granelli, et al., reported on the results of screening 39,821 newborn subjects at five maternity centers in Sweden. Investigators used the Masimo Radical™ with Masimo SET® technology, and found pulse oximetry screening of all well babies in maternity units is practically feasible with a minimum use of nursing time, and that it significantly improves detection of duct dependent heart disease before hospital discharge. The low false positive rate, the fact that other important pathology is unearthed by the screening, and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective.

Dr. Andrew Ewer, et al., studied 20,055 newborn subjects at six maternity centers in the UK. Investigators used the Radical-7® with Masimo rainbow® SET® technology and found pulse oximetry to be a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography, and the early detection of other diseases is an additional advantage.

Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (CCHD)

Masimo Announces HEART Program for CCHD Screening to Provide a Free Masimo SET® Pulse Oximeter to Hospitals in Need

Irvine, California – September 24, 2012 – Masimo (NASDAQ: MASI) announced today that it has received U.S. FDA 510(k) clearance for Masimo Signal Extraction Technology® (SET®) pulse oximeters, rainbow® SET® Pulse CO-Oximeters®, and neonatal sensors with labeling for screening newborns for critical congenital heart disease (CCHD). Masimo SET® pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but this marks the first time the FDA has cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

In conjunction with the FDA clearance, Masimo also announced the HEART Program (Help Ensure Access to the Right Technology) for CCHD screening enabling hospitals in countries where Masimo has a presence that want to perform CCHD screening with a Masimo SET® pulse oximeter, but do not have one and do not have funds to purchase one, to receive a free Masimo SET® pulse oximeter. More details are available at www.masimo.com/heartprogram.

CCHD causes up to 3% of all infant deaths in the first year of life.1 According to the U.S. Department of Health and Human Services (HHS), these types of heart defects affect about 7 to 9 of every 1,000 live births, one quarter of which could be detected and potentially treated by measuring blood oxygen saturation. FDA clearance comes as California recently became the latest state to mandate CCHD pulse oximetry screening (http://www.aroundthecapitol.com/Bills/AB_1731/20112012/), following HHS’s September 2011 action to add pulse oximetry CCHD screening for newborns as part of the Recommended Uniform Screening Panel.

HHS took this action based on the published findings of the CCHD Workgroup,2 which relied on two major independent, published, prospective clinical studies that exclusively used Masimo SET® Measure-Through Motion and Low Perfusion pulse oximeters to recommend screening with “motion-tolerant pulse oximeters” that “have been validated in low perfusion conditions.” Both of the studies were submitted by Masimo to the FDA to support the new CCHD screening labeling.

Dr. Anne de-Wahl Granelli, et al., reported on the results of screening 39,821 newborn subjects at five maternity centers in Sweden. Investigators used the Masimo Radical™ with Masimo SET® technology, and found pulse oximetry screening of all well babies in maternity units is practically feasible with a minimum use of nursing time, and that it significantly improves detection of duct dependent heart disease before hospital discharge. The low false positive rate, the fact that other important pathology is unearthed by the screening, and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective.3

Dr. Andrew Ewer, et al., studied 20,055 newborn subjects at six maternity centers in the UK. Investigators used the Radical-7® with Masimo rainbow® SET® technology and found pulse oximetry to be a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography, and the early detection of other diseases is an additional advantage.4

In spite of the wide availability of Masimo SET® pulse oximetry, both as standalone products as well as integrated products in over 100 multiparameter monitors from over 50 brands, some hospitals still do not have Masimo SET® technology. Given the strong evidence supporting the use of Masimo SET pulse oximetry for CCHD screening and Masimo’s commitment to help save and improve babies’ lives through expanded CCHD screening programs, the company’s HEART Program (Help Ensure Access to the Right Technology) for CCHD screening will help ensure that hospitals have access to Masimo SET technology for CCHD screening.

“We are very proud of where we have taken pulse oximetry,” stated Masimo founder and CEO, Joe Kiani. “Before SET pulse oximetry, CCHD screening was impractical, if not impossible with pulse oximetry. Dr. Graneli’s initial study showed that even a so called ‘next generation’ pulse oximeter wasn’t able to reliably work for CCHD screening, and was abandoned in the middle of the trial, while Masimo SET delivered the groundbreaking results of high sensitivity and specificity that became the basis for this new standard of care. We are truly elated with this new FDA clearance. We feel that with it, comes the responsibility to make CCHD pulse oximetry screening more accessible for infants, the most defenseless patients in any healthcare setting. We are excited to announce that, in conjunction with this new FDA clearance, we are launching the HEART Program for CCHD screening—offering a free Masimo SET® pulse oximeter to hospitals that need one but can’t afford it. In this way, we are helping to address unmet needs on behalf of newborns around the world.”

The Masimo pulse oximeters that were the subject of this 510(k) clearance are the Radical-7®, Rad-57™ and Rad-87™ Pulse CO-Oximeters with Masimo rainbow SET, and the Rad-5®, Rad-5v™ and Rad-8® Pulse Oximeters with Masimo SET.

* Hospitals must be located in a country where Masimo has a presence. Offer subject to rules and regulations of the country where the hospital is located. Full program details and eligibility requirements available at: www.masimo.com/heartprogram.

1 Secretary of Health & Human Services letter to the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC); dated September 21, 2011. Available here

2 Alex R. Kemper, William T. Mahle, Gerard R. Martin, W. Carl Cooley, Praveen Kumar, W. Robert Morrow, Kellie Kelm, Gail D. Pearson, Jill Glidewell, Scott D. Grosse, R. Rodney Howell. “Strategies for Implementing Screening for Critical Congenital Heart Disease.” Pediatrics; Volume 128, No. 5; November 2011; e1-w10 DOI: 10.1542/peds.2011-1317. Available here

3 De-Wahl Granelli et al., “Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns.” British Medical Journal (BMJ) January 2009; 338:a3037.

4 Ewer et al., “Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study.” The Lancet 2011: Vol. 378; No. 9793; pp. 785-794.

Additional references: De-Wahl Granelli A,Mellander M, Sunnegardh J, Sandberg K, ?stman-Smith I. “Screening for duct-dependent congenital heart disease with pulse oximetry: a critical evaluation of strategies to maximize sensitivity.” Acta Paediatr 2005;94:1590-6. Available here.

Wren C, Richmond S, Donaldson L. “Presentation of congenital heart disease in infancy: implications for routine examination.” Arch Dis Child Fetal Neonatal Ed. 1999;80:F49–F53. Available here.

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve “unsolvable” problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry’s ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo’s rainbow® SET® technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. In 2012, Masimo acquired assets of Spire Semiconductor, LLC, maker of advanced light emitting diode (LED) and other advanced component-level technologies; and acquired PHASEIN AB, a developer and manufacturer of ultra-compact mainstream and sidestream capnography, multigas analyzers, and handheld capnometry solutions. Masimo SET® and Masimo rainbow® SET® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of “Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications®.” Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Source :http://www.masimo.com/news/index.cfm#3407

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Eulerian Video Magnification Technology Reveals Moments That Occur in the Blink of an Eye

Eulerian Video Magnification Technology Reveals Moments That Occur in the Blink of an Eye

Eulerian Video Magnification Technology Reveals Moments That Occur in the Blink of an Eye

An example of using our Eulerian Video Magnification framework for visualizing the human pulse. (a) Four frames from the original video sequence. (b) The same four frames with the subject’s pulse signal amplified. (c) A vertical scan line from the input (top) and output (bottom) videos plotted over time shows how our method amplifies the periodic color variation. In the input sequence the signal is imperceptible, but in the magnified sequence the variation is clear.

An example of using our Eulerian Video Magnification framework for visualizing the human pulse. (a) Four frames from the original video sequence. (b) The same four frames with the subject’s pulse signal amplified. (c) A vertical scan line from the input (top) and output (bottom) videos plotted over time shows how our method amplifies the periodic color variation. In the input sequence the signal is imperceptible, but in the magnified sequence the variation is clear.

Here’s a video overview of some interesting research that’s being done in the area of video processing. By taking standard video as an input and doing some fancy technical mojo on it, researchers are able to amplify information in it to reveal things that are virtually invisible to the human eye. For example, you can detect a baby’s heartbeat by simply pointing a camera at his/her face. The method is able to visualize the pulsating flow of blood that fills the face.

MIT researchers are developing some interesting technology that could supercharge our cell phone cameras. Dubbed “Eulerian Video Magnification”, the project’s goal is to amplify “hidden” information by revealing the subtle changes in standard video too difficult for the naked eye to detect. For example, you can input a video of a person simply staring at the camera, process it with the video magnification technology, and it’ll output a video that shows the person’s face pulsating red to visualize the actual flow of blood in and out of the face. The technology is powerful enough to even detect the pulsations of the radial artery in a video of one’s wrist. It’s amazing stuff, and it brings a lot of potential for contact-free medical sensors and monitoring devices.

Take a look at the video below explaining the technology and demonstrating some examples. There’s a lot of technical jargon, so you may want to skip ahead to the 1:25 mark to see the really cool stuff.

Source : http://www.petapixel.com/2012/06/13/magnifying-the-subtle-changes-in-video-to-reveal-the-invisible/

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PEEK Orthopedic Implant Uses Stem Cells to Increase Strength and Longevity

PEEK Orthopedic Implant Uses Stem Cells to Increase Strength and Longevity

PEEK Orthopedic Implant Uses Stem Cells to Increase Strength and Longevity

Scientists at the University of Glasgow are working to harness the regenerative power of stem cells to improve orthopaedic implant surgery.

They are collaborating with surgeons at Glasgow’s Southern General Hospital to develop a new type of orthopaedic implant which could be considerably stronger and more long-lived than the current generation of products.

Currently, implants are commonly made from materials such as polyethylene, stainless steel, titanium or ceramic and have a limited lifespan due to loosening, requiring replacement after 15 or 20 years of use. In hip replacement surgery, the head of the thigh bone is removed and replaced with an implant which is held in place by a rod fixed inside the marrow along the length of the bone.

Marrow is a rich source of mesenchymal stem cells, which have the potential to divide, or ‘differentiate’, into other types of cells such as skin, muscle or bone which can improve the process of healing. However, stem cells can also differentiate into cells which have no use in therapy. Artificially controlling the final outcome to ensure the desired type of cells are created is very difficult, even under laboratory conditions.

When traditional implants are fixed into bone marrow, the marrow’s stem cells do not receive messages from the body to differentiate into bone cells, which would help create a stronger bond between the implant and the bone. Instead, they usually differentiate into a buildup of soft tissue which, combined with the natural loss of bone density which occurs as people age, can weaken the bond between the implant and the body.

The team from the University of Glasgow’s Colleges of Science and Engineering and Medical, Veterinary and Life Sciences have found a reliable method to encourage bone cell growth around a new type of implant. The implant will be made of an advanced implantable polymer known as PEEK-OPTIMA®, from Invibio® Biomaterial Solutions, which is already commonly used in spinal and other orthopaedic procedures.

Dr Matthew Dalby, of the University’s Institute of Molecular, Cell and Systems Biology, explained: “Last year, we developed a plastic surface which allowed a level of control over stem cell differentiation which was previously impossible. The surface, created at the University’s James Watt Nanofabrication Centre, is covered in tiny pits 120 nanometres across. When stem cells are placed onto the surface, they grow and spread across the pits in a way which ensures they differentiate into therapeutically useful cells.

“By covering the PEEK implant in this surface, we can ensure that the mesenchymal stem cells differentiate into the bone cells. This will help the implant site repair itself much more effectively than has ever been possible before and could well mean that implants will last for the rest of patient’s life.”

Dr Dalby added: “People are living longer and longer lives nowadays; long enough, in fact, that we’re outliving the usefulness of some of our body parts. Our new implant could be the solution to the expensive and painful follow-up surgeries which conventional implants require.”

The team is supported by the UK biomaterial solutions provider Invibio, the world’s leading provider of PEEK-based materials.

Dr Nikolaj Gadegaard, Senior Lecturer in Biomedical Engineering at the University, explained: “One of the main selling points of PEEK is that it is very strong, has excellent stability and is very resistant to wear. However, the inertness of the material is not always suitable for implants that require some interaction with the surrounding tissue. Our nanopatterned surface may allow Invibio’s PEEK polymer to interact with stem cells and enable an effective integration between the implant and the body for the first time.

“Another benefit of PEEK is that it matches the mechanical properties of our own bodies much better than traditional materials. While bone has a certain amount of flex to it, the use of inflexible titanium in implants results in loss of bone density because the bone is not exercised. The flexibility of PEEK is similar to that of bone, and will allow the implant to flex in a natural manner, significantly helping the process of bone regeneration.”

“PEEK products can be made using an injection-moulding technique. Although our nanopatterned surface is complex, the process of production is similar to that which makes Blu-Ray discs, which means that future mass-production of the implant is a very real possibility.”

The partnership between the University’s academics and surgeons at the Southern General is a result of the Glasgow Orthopaedic Research Initiative (GLORI). GLORI, formed in 2009, aims to foster collaboration between scientists and clinicians to turn novel materials research into the next generation of orthopaedic care.

Dominic Meek, Consultant in Orthopaedics and Trauma Surgery at Glasgow’s Southern General Hospital, has been participating in the development of the new implant. He said: “I originally began working with Dr Dalby and Dr Gadegaard to supply samples of bone marrow stem cells for their research but it quickly became clear that their work had a lot of potential for direct applications in my area of surgery.

We’ve been working closely together ever since and we’ve created an enthusiasm for orthopaedic research in the west of Scotland which has been re-emerging over the last 15 years or more. Four postgraduate students have completed MDs or PhDs related to the subject and we currently have a team of six students, clinical fellows and post-doctoral researchers focusing on this new innovation.

“It’s an extremely exciting project to be working on, with implications for improving a wide range of joint replacements and other orthopaedic surgeries. We’re keen to see a prototype ready for use in hip replacement surgery within a decade.”

The research to date has been funded by the Biotechnology and Biological Sciences Research Council (BBSRC), the Medical Research Council (MRC), the Engineering and Physical Sciences Research Council (EPSRC), the Scottish Government’s Chief Scientist Office and the European FP7 project NaPANIL.

Orthopedic procedures, such as hip replacement surgeries, restore mobility to thousands of people each year, but current technology makes them far from perfect. Current implants use polyethylene, stainless steel, titanium or ceramic, which each have their own drawbacks ranging from biocompatability issues, which could lead to infection, to inflexibility, which can lead to the loss of bone density. Moreover, when an implant is placed, it is usually held in place by a rod that is fixed into the marrow of a bone. Bone marrow, which is rich in stem cells that can differentiate into many different kinds of cells, tends to differentiate into soft tissue, which weakens the bond between bone and implant, requiring replacement surgery after 20 or so years.

Researchers as the University of Glasgow in Scotland, however, have developed an orthopedic implant that addresses many of these issues and could very well last for the rest of a patient’s life. The key ingredient of this new, super-strong implant is Invibio Biomaterial Solutions‘ PEEK-OPTIMA, an advanced polymer that is already commonly used in spinal and other orthopedic implants. PEEK is not only biocompatible, but is also flexible; because its mechanical properties are similar to bone, PEEK implants can flex and exercise the surrounding bone, which promotes bone regeneration.

Moreover, the implant is covered with a special surface consisting of tiny pits 120 nanometers in diameter. The pitted surface encourages stem cells to differentiate into bone cells and fuse to the implant, creating a much stronger bond between bone and implant.

An added benefit to potential users of the implant is that they can be made using an injection-molding technique, which could keep costs low by allowing for mass production.

Source : http://www.gla.ac.uk/news/headline_240245_en.html

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Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

Brainsway Deep TMS EU Cleared for Neuropathic Chronic Pain

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient’s scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain’s neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.

Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

The unique technology of Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures.

Deep TMS is a breakthrough in the search for a non-invasive approach for treating common brain disorders. Deep TMS uses a unique, patented coil design to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, no systemic effect (in contrast to drugs), and no need of hospitalization or anesthesia.

JERUSALEM, Jul 2, 2012 (GlobeNewswire via COMTEX) — Brainsway Ltd. (tase:BRIN) is pleased to announce that it has received CE Mark enabling commercialization of its Deep TMS system to treat neuropathic chronic pain (“neuropathic pain”) in the European Union and the countries in Asia and Latin America that recognize the CE Mark.

“Neuropathic pain is the sixth indication for which Deep TMS has achieved CE Mark approval,” commented Uzi Sofer, Brainsway’s CEO. “Previous CE Marks were for clinical depression, bi-polar disorder, schizophrenia (negative symptoms), Parkinson’s diseases and post-traumatic stress disorder. As our therapeutic pipeline continues to expand, it is very exciting to continue to bring proven new Deep TMS treatments to market.”

About Brainsway Ltd.

Brainsway is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimluation) systems – novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method. Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson’s disease, Alzheimer’s disease, autism and post-traumatic stress disorder. Our initial focus is the treatment of major depression. The unique technology of Brainsway is based on patents filed by the U.S. National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Headquartered in Jerusalem, Israel, the company’s ordinary shares and warrants trade on the Tel Aviv Stock Exchange under the symbol ‘BRIN’.

Forward-Looking Statements

This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company’s ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.

This news release was distributed by GlobeNewswire, www.globenewswire.com

Brainsway‘s transcranial magnetic stimulation (TMS) technology is finding itself useful in ever more clinical applications as the European Union just issued the CE Mark for the company’s Deep TMS system to be used for treatment of neuropathic chronic pain.

Brainsway Deep TMS H Brainsways Deep TMS EU Cleared for Neuropathic Chronic Pain

The technology delivers targeted magnetic pulses deep into the brain, inducing electrical signals that can activate neurons in the localized region, which seems to help for a number of disorders. The System already has the CE Mark indicating its use for clinical depression, bi-polar disorder, schizophrenia (negative symptoms), Parkinson’s diseases and post-traumatic stress disorder.

Brainsway, a firm building transcranial magnetic stimulation systems (TMS) out of Jerusalem, Israel, just received European approval to market its devices for the treatment of depression. The TMS treatment is likely to be used initially for cases of severe drug resistant depression. But we can envision a day when this technology becomes a mainstream therapeutic option for bipolar disorder and some other psychiatric diseases.

About the technology from Brainsway:

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient’s scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain’s neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.

Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

Source : http://www.brainsway.com/Brainsway/Templates/showpage.asp?DBID=1&LNGID=1&TMID=84&FID=346

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