Archive for August 2nd, 2012

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Johns Hopkins Students Win Grant for Saving Lives at Birth

Johns Hopkins Students Win Grant for Saving Lives at Birth

Johns Hopkins Students Win Grant for Saving Lives at Birth

Could a low-cost screening device connected to a cellphone save thousands of women and children from anemia-related deaths and disabilities?

That’s the goal of Johns Hopkins biomedical engineering undergraduates who say they’ve developed a noninvasive way to identify women with this dangerous blood disorder in developing nations. The device is designed to convert the existing cellphone lines of health workers into a “prick-free” system for detecting and reporting anemia at the community level.

The students’ project, HemoGlobe, recently received a boost when it was awarded a $250,000 seed grant in the Saving Lives at Birth: A Grand Challenge for Development competition. The event, which attracted more than 500 entrants from 60 countries, was sponsored by prominent global health organizations, including the U.S. Agency for International Development and the Bill & Melinda Gates Foundation. Only 12 entrants were awarded seed grants.

“When we thought about the big-name corporations and nonprofit groups we were competing against, we were amazed and surprised to find out that our team had won,” said team member George Chen, a sophomore majoring in biomedical engineering.

Chen attended the July 14 announcement ceremony in Seattle, along with Soumyadipta Acharya, the project’s faculty adviser and principal investigator, and team members Noah Greenbaum and Justin Rubin.

Acharya, an assistant research professor in the Department of Biomedical Engineering, said that the Saving Lives win showed that his students had taken an important step toward reducing anemia-related deaths in developing countries. “This device has the potential to be a game changer,” Acharya said. “It will equip millions of health care workers across the globe to quickly and safely detect this debilitating condition in pregnant women and newborns.”

The undergraduates he supervised spent a year brainstorming and building a prototype for a biomedical engineering design team class. The $250,000 will allow the students to refine their technology, as well as support field testing next year in Kenya by Jhpiego, a Johns Hopkins affiliate that provides global health training and services for women and their families. Jhpiego sponsored the HemoGlobe project through a partnership with the university’s Center for Bioengineering Innovation and Design.

Team member Greenbaum, a senior majoring in biomedical and electrical engineering, has continued working on the anemia system this summer. “The first year we just focused on proving that the technology worked,” he said. “Now, we have a greater challenge: to prove that it can have a real impact by detecting anemia and making sure the mothers get the care they need.”

The student inventors were looking for a new way to curb a stubborn health problem in developing nations. Anemia occurs when a person has too few healthy red blood cells, which carry critical oxygen throughout the body. This is often due to a lack of iron, and therefore a lack of hemoglobin, the iron-based protein that helps red blood cells store and release oxygen. Anemic mothers face many complications before and during birth, including death from blood loss after the delivery. In addition, a baby that survives a birth from an anemic mother may face serious health problems.

Global health researchers estimate that that anemia contributes to 100,000 maternal deaths and 600,000 newborn deaths annually. Health officials in developing countries have tried to respond by making iron supplements widely available. But, according to Acharya, the problem of anemia remains intractable. “So we looked at it from a different angle,” he said.

In places where medical care is easily accessible, doctors routinely test pregnant women for anemia and prescribe treatment, including routine iron supplementation. But in developing regions, where medical help is not always nearby, the condition may go undetected. However, community health workers with limited training do serve these areas.

“The team members realized that every community health worker already carries a powerful computer in their pocket—their cellphone,” Acharya said. “So we didn’t have to build a computer for our screening device, and we didn’t have to build a display. Our low-cost device will use the existing cellphones of health workers to estimate and report hemoglobin levels.”

The sensor, placed on the patient’s fingertip, shines different wavelengths of light through the skin to measure the hemoglobin level in the blood. On their phone’s screen, community health workers will quickly see a color-coded test result, indicating cases of anemia, from mild to moderate and severe.

If anemia is detected, women would be encouraged to follow a course of treatment, ranging from taking iron supplements to visiting a clinic or hospital for potentially lifesaving treatments. After every test, the phone would send an automated text message with a summary of the results to a central server, which would produce a real-time map showing where anemia is prevalent. This information could facilitate follow-up care and help health officials allocate resources where the need is most urgent.

The HemoGlobe student inventors have estimated that their cellphone–based systems could be produced for $10 to $20 each. A provisional patent covering the invention has been obtained through the Johns Hopkins Technology Transfer Office.

In addition to Chen, Greenbaum and Rubin, Whiting School of Engineering students who have participated on the team are Guilherme Barros, William Chen, Judy Doong, Phillip Oh and David Yin.

It’s impossible to deny how ubiquitous the cell phone has become, even in underdeveloped nations. So it comes as no surprise that innovators are looking to use cell phones as a platform to provide access to diagnostics-based technology, among others. An undergraduate student project at Johns Hopkins University, HemoGlobe, was recently awarded a $250,000 seed grant from the Saving Lives at Birth: A Grand Challenge for Development competition, which was sponsored by prominent global health organizations, including the U.S. Agency for International Development and the Bill & Melinda Gates Foundation.

The low cost screening device is aimed at a “prick free” method for identifying individuals with anemia in developing nations, in particular pregnant women and newborns who die from 100,000 maternal deaths and 600,000 newborn deaths annually.

The device, which is estimated to be manufactured at $10-20 [phone not included], consists of a sensor connected to a cell phone. The sensor, which emits different wavelength of light through the skin, detects the hemoglobin level in the blood. The output display on the cell phone screen is in the form of a colored dashboard with a ranking from mild to severe. Using these electronic records, health care workers can track, in real time, the prevalence of anemia in different regions and help to ensure that urgent care is provided to the areas that need it first.

From the JHU Gazette:

In places where medical care is easily accessible, doctors routinely test pregnant women for anemia and prescribe treatment, including routine iron supplementation. But in developing regions, where medical help is not always nearby, the condition may go undetected. However, community health workers with limited training do serve these areas.

“The team members realized that every community health worker already carries a powerful computer in their pocket—their cellphone,” Acharya [an assistant research professor in the Department of Biomedical Engineering] said. “So we didn’t have to build a computer for our screening device, and we didn’t have to build a display. Our low-cost device will use the existing cellphones of health workers to estimate and report hemoglobin levels.”

Source : http://gazette.jhu.edu/2012/07/23/students-cellphone-screening-device-for-anemia-wins-250000-prize/

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Boston Sci’s INGENIO and ADVANTIO Pacers Cleared in EU for Use Under MRI

Boston Sci’s INGENIO and ADVANTIO Pacers Cleared in EU for Use Under MRI

Boston Sci’s INGENIO and ADVANTIO Pacers Cleared in EU for Use Under MRI

PARIS (July 27, 2012) — Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for use of its INGENIO™ and ADVANTIO™ pacemakers in patients in need of a magnetic resonance imaging (MRI) scan. Now equipped with new Image Ready™ technology, the first European implants of the INGENIO MRI pacemaker are being performed in the United Kingdom by Dr. John Bayliss, Consultant Cardiologist at Watford General Hospital, London, in Italy by Prof. Massimo Santini, Director of Cardiology Department, San Filippo Neri, Roma, and in Germany by Dr. Joern Schmitt, Oberarzt der Justus-Liebig Universitätsklinik Gießen.

Pacemakers are designed to treat bradycardia, a condition in which the heart beats too slowly, depriving the body of sufficient oxygen. Many patients with pacemakers are restricted from undergoing MRI procedures as magnets may interfere with pacemaker functionality, or cause heating of the lead. With Image Ready technology, INGENIO MRI pacemakers, in combination with FINELINETM II leads, allow patients to undergo MRI procedures as needed.

“A significant number of patients with pacemakers may be affected by other conditions, which often require MRI scanning,” said Prof. Santini. “The ability for these patients to undergo detection of other conditions is an important advancement in improving overall patient health and outcomes.”

FINELINE II pacing leads are backward MRI compatible and therefore replacement of the lead is not required when implanting the new INGENIO MRI or ADVANTIO MRI pacemakers. More than one million FINELINE II leads have to date been implanted worldwide.

The INGENIO and ADVANTIO pacemakers were first approved in Europe in April 2012. Featuring RightRate™ pacing technology, the devices are designed to treat chronotropic incompetence, a form of bradycardia in which the heart is unable to regulate its rate appropriately in response to physical activity. Chronotropic incompetence affects up to 42 percent of pacemaker patients.

“The ability to use the INGENIO platform during MRI procedures is a significant advancement to our family of bradycardia devices,” said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. “This progression in the use of the INGENIO family of pacemakers represents another step in our commitment to expanding our pacing capabilities and improving the lives of patients.”

The INGENIO family of pacemakers is compatible with the new LATITUDE™ NXT Remote Patient Management system, which enables physicians to conduct remote follow-ups to monitor specific pacemaker information and heart health status. The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology. LATITUDE NXT is also compatible with the wireless weight scale and blood pressure monitor from Boston Scientific. Physicians can choose to remotely monitor a series of relevant health status indicators including weight and blood pressure, as well as respiratory and sleep apnea trending. Centers across Europe are currently enrolling patients in the LATITUDE NXT program.

For more news about Boston Scientific please follow us on Twitter @bsc_eu_heart (https://twitter.com/#!/BSC_EU_Heart).

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer, and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding regulatory approvals, product performance and effects, competitive offerings, markets for our products and our business plans. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Boston Scientific received FDA approval and is releasing in the U.S. the INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).

The devices are indicated for treatment of bradycardia, and the INGENIO and ADVANTIO pacemakers specifically feature BostonSci’s RightRate technology for addressing chronotropic incompetence, a condition in which the heart is unable to regulate its rate appropriately in response to physiologic stress, such as an exercise.

More from the announcement:

RightRate employs Boston Scientific’s minute ventilation (MV) sensor, the only sensor clinically proven to restore chronotropic competence, and adds programming options to promote ease of use and in-clinic time savings.

In addition to RightRate, the INGENIO pacemaker offers Respiratory Rate Trend (RRT), an exclusive feature that monitors respiration – a key vital sign. The INVIVE CRT-P offers RRT as part of HF Perspectiv™ – a comprehensive suite of heart failure diagnostics designed to provide health care professionals with additional information to guide treatment decisions.

The INGENIO, ADVANTIO and INVIVE devices are designed for use with Boston Scientific’s new LATITUDE™ NXT Remote Patient Management system, which is currently under review by the FDA, and will enable physicians to conduct remote follow-ups of these device patients to monitor specific pacemaker information and heart health status. The system is designed to detect clinical events between scheduled visits and send relevant data directly to a secure physician-accessible website via landline or cellular-based telephone technology using AT&T’s wireless network, under an agreement between Boston Scientific and AT&T.

In April, the company announced CE Mark approval and European market launch of the INGENIO and ADVANTIO pacemakers and INVIVE CRT-P.

Source : http://bostonscientific.mediaroom.com/index.php?s=24889&item=130968

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Todd Park on The Awesome Potential of Hidden Medical Data

Todd Park on The Awesome Potential of Hidden Medical Data

Todd Park, the Chief Technology Officer of the United States, spoke at the last TEDMED about vast amounts of data trapped within government agencies that needs to be “liberated” so that private players can create “awesomeness” out of it. The Department of Health and Human Services (HHS) in particular has gigabytes of all kinds of medical information on millions of people that should be mined for useful findings, but that first needs to be made easily accessible.

Todd Park on The Awesome Potential of Hidden Medical Data

The Department of Health and Human Services (HHS) hasn’t traditionally been thought of as a bold, risk-taking agency. HHS Chief Technology Officer (CTO) Todd Park has been working hard to change that. Park, who co-founded healthcare technology firm Athenahealth and later Castlight Health, was offered his current position two years ago. HHS asked Park to come work for them as an entrepreneur in residence. “The [CTO] job title is a little bit of a red herring; I actually don’t run technology at HHS. I’m 100% focused on being an internal change agent,” Park said at a recent roundtable meeting with journalists on September 23. His main task is to help the agency figure out how to tap “the power of data and technology in innovative ways to improve the health of the American people.”

“They brought me in as an entrepreneur,” Parks says. “But what I would say is that the most entrepreneurial years of my life have been the last two, because [HHS has been] launching initiatives that behave very much like Silicon Valley startups,” he explains. “There are interdisciplinary teams that work on Silicon Valley time in hyperrapid cycles in a really lean, startup style way. And these incredibly talented groups of HHS-ers have done just incredible things.”

The first example Park cited was the Health Data Initiative. “Basically it’s an initiative to turn HHS into what we are calling the NOAA [pronounces "Noah"] of health data. “NOAA actually, pretty famously, not just collects tons and tons of weather data, but publishes it online in machine-readable format, downloadable by anybody for free without intellectual property constraint,” Park says. “It then feeds a massive array of private sector innovations like Weather Channel, Weather.com, iPhone weather apps, etc. that creates huge value for the American people.”

Park also points out the availability of GPS data, which was made public in the 80?s. That data now feeds everything from FourSquare, supertanker navigation systems, and everything in between, he says. The Health Data Initiative is an attempt to do the same thing for healthcare. “We want to open up the data and stimulate massive private sector innovation play—this time, with vast amounts of health-related data that are sitting in the vaults of HHS.”

HHS is releasing data that has never been released before and also improving access to data that has already been published. “[This data] has been public in the sense that it’s in books, PDFs, and static webpages, and we’re turning it into forms that developers can actually use,” Park explains. This will “enable the data to become liquid and then be used as fuel for other applications, services, and products.”

“We are marketing the bejesus out of our data to the innovators of the country,” Park says. Park referenced an “unscientific, but pretty definitive survey of innovators” that indicated 98% of the people capable of doing stuff with with the data didn’t even know that we had this data, let alone that we were making it available to them.”

An Ecosystem of Innovation and Joy’s Law

HHS has set up a site to help get the word out that this data is available: Health.Data.gov. The objective is to “[stimulate] innovators to use our data as fuel in applications, products, and services that improve health and healthcare, and create jobs at the same time,” Park says. The real goal behind the efforts is to “stimulate the emergence of an ecosystem of innovation that sits on top of open health data,” he adds.

“The fundamental precept that drives the whole thing is one our favorite laws in the universe—Joy’s Law,” he adds. “Bill Joy, the co-founder of Sun Microsystems, famously said once that no matter who you are, you have to remember that most of the smart people in the world work for someone else.”

Park seeks to exploit Joy’s law to drive innovation. As he explained at the roundtable discussion:

And so the whole underlying assumption behind the Health Data Initiative Forum is that the best way for us to have our data to have a positive impact is not just for our own smart people to use it, but for all of the other smart people in the world to be able to get access to it and use it to improve health and healthcare.

Maybe the best example of how it has mushroomed is [...] “Health Data-Palooza.” (I think the formal name was the Health Data Initiative Forum, but I keep calling it the “Health Data-Palooza.”) And it was executed by the Institute of Medicine and by HHS in Bethesdsa, Maryland, actually. And we issued a open call for people to submit proposals to do TED-style talks—basically short, focused presentations of services, applications, solutions they had built that were powered in part by our data that helped consumers take control of their own health and healthcare, get the information that they need, help doctors and hospitals deliver better care, help employers promote health and wellness, help journalists write better stories, help mayors make better decisions, etc. And the criteria were: they had to add value for one of those constituencies in a very concrete way and secondly, the innovation had to have a sustainable business model. So we weren’t interested in [something analogous to] concept cars that no one would drive; we only were interested in services that could be delivered to actual people, today. Even with those criteria, only 18 months into this, we were overwhelmed by the number of people who had solutions that were compelling. We ended up doing an American Idol-style bake off process, where the innovators would present and the judges would give thumbs up or thumbs down.

We like to joke now that I was Paula Abdul. I was weeping constantly in joy. Greg [Downing] [Program Director, Personalized Health Care Initiative at HHS] was Simon Cowell saying, well, I don’t know. So with Greg’s help we were able to narrow it down to about 50 companies and other organizations that had deployed these incredible solutions and, if you are curious to see what they are all about, you can go to the Institute of Medicine’s website and look up the June 9th, 2011 Health Data Initiative Forum and you can see all 50-some presentations and they are incredibly inspiring and just illustrate how beautifully out of control this whole ecosystem is already.

Park adds that there a number of other initiatives and policies that are in place, like ones mentioned above and the CMS Innovation Center, “that are explicitly meant to catalyze innovation across the country.” Of course, it’s important for innovators to actually know that this work is going on. “So, we’ve been doing a ton and we are going to do a lot more outreach to the innovator community to help them understand what we are trying to do to be helpful and, A, you know, we hope that helps to catalyze activity, which it definitely has been, and B, get feedback about what we are doing so we can actually improve it. Because the point of all of this is work is to support them.”

Source :http:harnessing-the-power-of-data-todd-park’s-vision-for-rebooting-u-s-healthcare.html

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Medtronic’s BSC 9.1S Bipolar Sealer with Cutting for Orthopaedic Surgery

Medtronic’s BSC 9.1S Bipolar Sealer with Cutting for Orthopaedic Surgery

Medtronic’s BSC 9.1S Bipolar Sealer with Cutting for Orthopaedic Surgery

Medtronic received FDA clearance and will begin making available in the U.S. its new Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting, a device that performs haemostatic sealing and coagulation of soft tissue and bone, and allows the surgeon to use it as a cutting instrument as well.

BSC 9.1S Bipolar Sealer with Cutting zoom Medtronics BSC 9.1S Bipolar Sealer with Cutting for Orthopaedic SurgeryBy bringing two tools into one, Medtronic hopes to save time during surgery while minimizing blood loss. Not having to switch between instruments while the blood is flowing can save seconds that are particularly important.

From the announcement:

Like other devices in the Aquamantys line, the BSC 9.1S uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and maintain patient hemoglobin levels when used during orthopaedic procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased hospital length of stay.

“The BSC 9.1S combining cutting and Transcollation into a single device could simplify workflow by reducing the number of tool changes and therefore may result in a time savings for the surgeon,” said Dr. Roger Emerson, a surgeon at Presbyterian Hospital, Baylor Regional Medical Center at Plano Joint Replacement Center.

MINNEAPOLIS – July 30, 2012 – Medtronic, Inc. (NYSE: MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business.

The BSC 9.1S Bipolar Sealer with Cutting gives surgeons the ability to optimize efficiency in surgical cases by combining hemostatic sealing capabilities for soft tissue and bone and monopolar cutting functionality in a single device. Like other devices in the Aquamantys line, the BSC 9.1S uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and maintain patient hemoglobin levels when used during orthopaedic procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased hospital length of stay.

“The BSC 9.1S combining cutting and Transcollation into a single device could simplify workflow by reducing the number of tool changes and therefore may result in a time savings for the surgeon,” said Dr. Roger Emerson, a surgeon at Presbyterian Hospital in Plano, Texas.

“We are excited to offer surgeons this new addition to our ever-growing orthopaedic portfolio of advanced energy products,” said Mark Fletcher, president of the Surgical Technologies business at Medtronic, Inc. “The BSC 9.1S utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery and combines it with the added benefit of integral cutting. It will deliver considerable value to surgeons, patients, and hospitals alike.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Source : http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1343305093587&lang=en_US

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Digirad X-ACT Solid State SPECT Approve

Digirad X-ACT Solid State SPECT Approve

Digirad X-ACT Solid State SPECT Approve

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Adds to International Distribution Network

POWAY, CA — (MARKET WIRE) — 01/25/12 — Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-based Bozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation

Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Forward-Looking Statements

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. These include statements regarding our ability to deliver value to customers and our expanded product and service offerings. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made, including the risks associated with changes in business conditions, technology, customers’ business conditions, reimbursement, radiopharmaceutical shortages, economic outlook, operational policy or structure, acceptance and use of Digirad’s camera systems and services, reliability, recalls, and other risks detailed in Digirad’s filings with the U.S. Securities and Exchange Commission, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other reports. Readers are cautioned to not place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Digirad undertakes no obligation to revise or update the forward-looking statements contained herein.

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

Source : http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

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Groundbreaking Personalized Cancer Immunotherapy Trial About to Start

Groundbreaking Personalized Cancer Immunotherapy Trial About to Start

PLEASE NOTE: As expected, Roswell Park Cancer Institute continues to receive a very high volume of calls and emails from patients and their families regarding the vaccine clinical research study that was announced at our press conference, January 24. Many calls and emails (and even some in-person inquiries) are coming into all sectors of the Institute – from the clinics and Switchboard to Patient Access and the Cancer Resource Center. The staff and faculty of Roswell Park are making every effort to ensure that you receive the information you need quickly and efficiently. Therefore, we ask that you ONLY contact the ASK-RPCI information center. To reach the ASK-RPCI information center, call 1-877-ASK-RPCI (1-877-275-7724), Monday through Friday, from 9 a.m. until 5:30 p.m. or send an email to askrpci@roswellpark.org. Information about the trial is also included on the Roswell Park website at www.roswellpark.org. Thank you for both your cooperation and your interest in this important new study.

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) has launched a phase I clinical research study of a dendritic cell vaccine designed to both eradicate cancer cells and prevent disease relapse. Developed at RPCI, the NY-ESO-1 dendritic cell vaccine will be manufactured in the Institute’s new Therapeutic Cell Production Facility using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

To learn more about the clinical research studies of the NY-ESO-1 dendritic cell vaccine, call 1-877-ASK-RPCI (1-877-275-7724).

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

Cells are becoming too valuable to do otherwise anymore!

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No cell should be left behind! No Cyto-Career should be either!

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells.

The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study,” according to the announcement.

The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

Source : http://www.roswellpark.org/media/news/roswell-park-launches-landmark-immunotherapy-vaccine-trial

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Stanford Partners with FDA to Improve Pre-Market Approval Process

Stanford Partners with FDA to Improve Pre-Market Approval Process

Stanford Partners with FDA to Improve Pre-Market Approval Process

I guess you could say that the Stanford Biodesign Program “wrote the book” on how to teach medical technology innovation to multidisciplinary teams. The U.S. Food and Drug Administration recently acknowledged the effectiveness of this training program by signing a “memorandum of understanding” with Stanford, which I discuss in today’s Inside Stanford Medicine.

The agreement lays the groundwork for the FDA and Stanford to collaborate on a number of initiatives, including educational outreach, cross-training of scientific personnel, and the development of new biostatistical methods for more accurately evaluating the safety of emerging medical technologies.

The biodesign program, which is in its 11th year, trains teams of doctors, engineers and business students — in an intensive one-year program — to identify a medical need, develop an invention to fill it, create a business plan, navigate the regulatory process, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.

Previously: Stanford Biodesign Program releases video series on the FDA system, FDA walks line between innovation and safety, Stanford physician-entrepreneur discusses need to change FDA approval process, and New biomedical device textbook gets early praise

The U.S. Food and Drug Administration has established a partnership with Stanford University to explore new ways to more quickly and safely bring lifesaving medical devices to market.

Initiated by Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, this collaboration is part of the agency’s larger effort to re-engineer and streamline the way the nation designs, tests and evaluates new medical technologies. The relationship was formalized with the signing of a “memorandum of understanding” on Jan. 12 during a roundtable discussion that included representatives from the FDA, the Stanford Biodesign Program and the California Healthcare Institute.

“This agreement is the first step in a new collaboration between the FDA and Stanford University to promote better scientific understanding and education concerning the development of new technologies in the life sciences and the issues that affect their safety and effectiveness” said Shuren. “We look forward to working together on collaborative research initiatives and the education of students and fellows.”

Related News

» Patent agency officials discuss how to reduce application backlog

» Top FDA official to discuss medical device innovation with industry leaders at Stanford

Although specific projects have yet to be defined, this agreement paves the way for both institutions to jointly apply for grants and extramural funds to support their mutual objectives. Stanford’s contributions primarily will focus on two areas — education on med-tech “best design practices” and the development of new methods for more accurately evaluating the safety of emerging medical technologies.

Paul Yock, MD, director of the biodesign program, will lead the effort to promote better design practices, which includes improving understanding of regulatory practices. The biodesign program, which is in its 11th year, provides medical technology innovation training to teams of doctors, engineers and business students who — in a year — identify a medical need, develop an invention to fill it, create a business plan, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.

Shuren, who calls Stanford’s biodesign program the “gold standard” of medical technology development programs, said that he will work with Yock to coordinate onsite cross-training of scientific personnel at the FDA and Stanford to foster the exchange of new ideas on more efficient regulatory processes.

Harry Greenberg, MD, director of Spectrum, the Stanford Center for Clinical and Translational Education and Research, is helping to lead a new initiative in predictive and precision medicine; it’s aimed at coordinating existing efforts in computational methodology, imaging and genetics with the goal of achieving higher and more efficient precision in diagnostic and prognostic efforts.

“Working with the FDA will offer Stanford trainees the potential for a firsthand exposure to the new field of regulatory science and at the same time allow FDA investigators the opportunity to become more familiar with some of the newest approaches to innovation and translation in the device and imagining space,” said Greenberg, who is also senior associate dean for research.

Stanford’s decade old biodesign program is partnering up with FDA Center for Devices and Radiological Health to help the agency adapt the way it screens new medical technologies.

The parties have reached a “memorandum of understanding,” rather than a formal agreement to specific projects, but the framework creates a method by which cooperation can now take place.

From the announcement:

“This agreement is the first step in a new collaboration between the FDA and Stanford University to promote better scientific understanding and education concerning the development of new technologies in the life sciences and the issues that affect their safety and effectiveness” said Shuren. “We look forward to working together on collaborative research initiatives and the education of students and fellows.”

Although specific projects have yet to be defined, this agreement paves the way for both institutions to jointly apply for grants and extramural funds to support their mutual objectives. Stanford’s contributions primarily will focus on two areas — education on med-tech “best design practices” and the development of new methods for more accurately evaluating the safety of emerging medical technologies.

Paul Yock, MD, director of the biodesign program, will lead the effort to promote better design practices, which includes improving understanding of regulatory practices. The biodesign program, which is in its 11th year, provides medical technology innovation training to teams of doctors, engineers and business students who — in a year — identify a medical need, develop an invention to fill it, create a business plan, then present their inventions to venture capitalists.

Source : http://med.stanford.edu/ism/2012/january/fda-0123.html

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New Fluorescent Technique Opens Window on Neuronal Activity

New Fluorescent Technique Opens Window on Neuronal Activity

New Fluorescent Technique Opens Window on Neuronal Activity

Researchers at the University of California, San Diego School of Medicine have created a new generation of fast-acting fluorescent dyes that optically highlight electrical activity in neuronal membranes. The work is published in this week’s online Early Edition of the Proceedings of the National Academy of Sciences.

The ability to visualize these small, fast-changing voltage differences between the interior and exterior of neurons – known as transmembrane potential – is considered a powerful method for deciphering how brain cells function and interact.

However, current monitoring methods fall short, said the study’s first author Evan W. Miller, a post-doctoral researcher in the lab of Roger Tsien, PhD, Howard Hughes Medical Institute investigator, UC San Diego professor of pharmacology, chemistry and biochemistry and 2008 Nobel Prize co-winner in chemistry for his work on green fluorescent protein.

“The most common method right now monitors the movement of calcium ions into the cell,” said Miller. “It provides some broad indication, but it’s an indirect measurement that misses activity we see when directly measuring voltage changes.”

Voltage Sensing Dyes

Leech neurons stained with voltage-sensitive dye.

The new method employs dyes that penetrate only the membrane of neurons, either in in vitro cells cultured with the dye or, for this study, taken up by neurons in a living leech model. When the dyed cells are exposed to light, neuronal firing causes the dye momentarily to glow more brightly, a flash that can be captured with a high-speed camera.

“One of the tradeoffs with using voltage-sensing dyes in the past is that when they were reasonably sensitive to voltage changes, they were slow compared to the actual physiological events,” said Miller. “The new dye gives big signals but is much faster and doesn’t perturb the neurons. We essentially see no lag time between the optical signal and electrodes (used to double-check neuronal activity).”

The new method provides a wider view of neuronal activity, said Miller. More importantly, it makes it possible for neuroscientists to do accurate, single trial experiments. “Right now, you have to repeat experiments with cells, and then average the results, which is physiologically less relevant and meaningful.”

For Tsien, the new dyes address a career-long challenge.

“These results are the first demonstration of a new mechanism to sense membrane voltage, which is particularly satisfying to me because this was the first problem I started working on as a graduate student in 1972, with little success back then,” said Tsien. “Later, we devised indirect solutions such as calcium imaging or dyes that gave big but slow responses to voltage. These techniques have been very useful in other areas of biology or in drug screening, but didn’t properly solve the original problem. I think we are finally on the right track, four decades later.”

Funding for this research came, in part, from the Howard Hughes Medical Institute, the National Institutes of Health, including the National Institute of Neurological Disorders and Stroke and the National Institute of Biomedical Imaging and Bioengineering.

Co-authors are John Y. Lin, Department of Pharmacology, UC San Diego; E. Paxon Frady, Neurosciences Graduate Group, UC San Diego; Paul A. Steinbach, Department of Pharmacology, UC San Diego and Howard Hughes Medical Institute; William B. Kristan, Jr., Division of Biological Sciences, UC San Diego.

Fluorescence imaging is an attractive method for monitoring neuronal activity. A key challenge for optically monitoring voltage is development of sensors that can give large and fast responses to changes in transmembrane potential. We now present fluorescent sensors that detect voltage changes in neurons by modulation of photo-induced electron transfer (PeT) from an electron donor through a synthetic molecular wire to a fluorophore. These dyes give bigger responses to voltage than electrochromic dyes, yet have much faster kinetics and much less added capacitance than existing sensors based on hydrophobic anions or voltage-sensitive ion channels. These features enable single-trial detection of synaptic and action potentials in cultured hippocampal neurons and intact leech ganglia. Voltage-dependent PeT should be amenable to much further optimization, but the existing probes are already valuable indicators of neuronal activity.

Studying neuronal activity has been difficult due to a lack of methods that provide localized, real time feedback. Researchers at University of California, San Diego School of Medicine have now developed a new technique that utilizes special voltage reactive dyes that only pass through the membrane of neurons. When light is applied to the dyed neurons, they glow slightly more in response. Because former techniques lacked precision, results of multiple experiments had to be averaged out in order to get a clear picture. With the new method, individual experiments on the activity of neurons can be conducted

From the announcement:

“One of the tradeoffs with using voltage-sensing dyes in the past is that when they were reasonably sensitive to voltage changes, they were slow compared to the actual physiological events,” said Miller [Evan W. Miller, a UCSD post-doc]. “The new dye gives big signals but is much faster and doesn’t perturb the neurons. We essentially see no lag time between the optical signal and electrodes (used to double-check neuronal activity).”

The new method provides a wider view of neuronal activity, said Miller. More importantly, it makes it possible for neuroscientists to do accurate, single trial experiments. “Right now, you have to repeat experiments with cells, and then average the results, which is physiologically less relevant and meaningful.”

For Tsien [Roger Tsien, PhD, Howard Hughes Medical Institute investigator, UC San Diego professor of pharmacology, chemistry and biochemistry and 2008 Nobel Prize co-winner in chemistry for his work on green fluorescent protein], the new dyes address a career-long challenge.

“These results are the first demonstration of a new mechanism to sense membrane voltage, which is particularly satisfying to me because this was the first problem I started working on as a graduate student in 1972, with little success back then,” said Tsien. “Later, we devised indirect solutions such as calcium imaging or dyes that gave big but slow responses to voltage. These techniques have been very useful in other areas of biology or in drug screening, but didn’t properly solve the original problem. I think we are finally on the right track, four decades later.”

Source : http://health.ucsd.edu/news/releases/Pages/2012-01-25-fluorescent-neurons.aspx

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T-rays: One Step Closer to the Medical Tricorder

T-rays: One Step Closer to the Medical Tricorder

T-rays: One Step Closer to the Medical Tricorder

Scientists have developed a new way to create electromagnetic Terahertz (THz) waves or T-rays – the technology behind full-body security scanners. The researchers behind the study, published recently in the journal Nature Photonics, say their new stronger and more efficient continuous wave T-rays could be used to make better medical scanning gadgets and may one day lead to innovations similar to the ‘tricorder’ scanner used in Star Trek.

In the study, researchers from the Institute of Materials Research and Engineering (IMRE), a research institute of the Agency for Science, Technology and Research (A*STAR) in Singapore, and Imperial College London in the UK have made T-rays into a much stronger directional beam than was previously thought possible, and have done so at room-temperature conditions. This is a breakthrough that should allow future T-ray systems to be smaller, more portable, easier to operate, and much cheaper than current devices.

The scientists say that the T-ray scanner and detector could provide part of the functionality of a Star Trek-like medical ‘tricorder’ – a portable sensing, computing and data communications device – since the waves are capable of detecting biological phenomena such as increased blood flow around tumorous growths. Future scanners could also perform fast wireless data communication to transfer a high volume of information on the measurements it makes.

T-rays are waves in the far infrared part of the electromagnetic spectrum that have a wavelength hundreds of times longer than those that make up visible light. Such waves are already in use in airport security scanners, prototype medical scanning devices and in spectroscopy systems for materials analysis. T-rays can sense molecules such as those present in cancerous tumours and living DNA, since every molecule has its unique signature in the THz range. They can also be used to detect explosives or drugs, for gas pollution monitoring or non-destructive testing of semiconductor integrated circuit chips.

Terahertz generation in new device

The electric field distribution generated by the antenna with close-up of nano-antennas

Current T-ray imaging devices are very expensive and operate at only a low output power, since creating the waves consumes large amounts of energy and needs to take place at very low temperatures.

In the new technique, the researchers demonstrated that it is possible to produce a strong beam of T-rays by shining light of differing wavelengths on a pair of electrodes – two pointed strips of metal separated by a 100 nanometre gap on top of a semiconductor wafer. The structure of the tip-to-tip nano-sized gap electrode greatly enhances the THz field and acts like a nano-antenna to amplify the wave generated. In this method, THz waves are produced by an interaction between the electromagnetic waves of the light pulses and a powerful current passing between the semiconductor electrodes. The scientists are able to tune the wavelength of the T-rays to create a beam that is useable in the scanning technology.

Lead author Dr Jing Hua Teng, from A*STAR’s IMRE, said: “The secret behind the innovation lies in the new nano-antenna that we had developed and integrated into the semiconductor chip.” Arrays of these nano-antennas create much stronger THz fields that generate a power output that is 100 times higher than the power output of commonly used THz sources that have conventional interdigitated antenna structures. A stronger T-ray source renders the T-ray imaging devices more power and higher resolution.

Research author Professor Stefan Maier in the laboratory

Research author Professor Stefan Maier in the laboratory

Research co-author Stefan Maier, a visiting scientist at A*STAR’s IMRE and Professor in the Department of Physics at Imperial College London, said: “T-rays promise to revolutionise medical scanning to make it faster and more convenient, potentially relieving patients from the inconvenience of complicated diagnostic procedures and the stress of waiting for accurate results. Thanks to modern nanotechnology and nanofabrication, we have made a real breakthrough in the generation of T-rays that takes us a step closer to these new scanning devices. With the introduction of a gap of only 0.1 micrometers into the electrodes, we have been able to make amplified waves at the key wavelength of 1000 micrometers that can be used in such real world applications.”

The research was led by scientist s from A*STAR’s IMRE and Imperial College London, and involved partners from A*STAR Institute for Infocomm Research (I2R) and the National University of Singapore. The research is funded under A*STAR’s Metamaterials Progr amme and the THz Programme, as well as the Leverhume Trust and the Engineering and Physical Sciences Research Council (EPSRC) in the UK.

An efficient, room-temperature-operation continuous-wave terahertz source will greatly benefit compact terahertz system development for high-resolution terahertz spectroscopy and imaging applications. Here, we report highly efficient continuous-wave terahertz emission using nanogap electrodes in a photoconductive antenna-based photomixer. The tip-to-tip nanogap electrode structure provides strong terahertz field enhancement and acts as a nano-antenna to radiate the terahertz wave generated in the active region of the photomixer. In addition, it provides good impedance-matching to the terahertz planar antenna and exhibits a lower RC time constant, allowing more efficient radiation, especially at the higher part of the terahertz spectrum. As a result, the output power of the photomixer with the new nanogap electrode structure in the active region is two orders of magnitude higher than for a photomixer with typical interdigitated electrodes. The terahertz emission bandwidth also increases by a factor of more than two.

Researchers from the Institute of Materials Research and Engineering, a collaboration between A-STAR in Singapore and Imperial College in London, have come up with a new way to create electromagnetic Teraherts waves (T-rays). The new technology can make T-rays into a stronger, more directional beam than current methods. This could allow T-ray devices to become much smaller and cheaper in the future. The results of their study were published in Nature Photonics.

Current T-ray imaging devices, like airport full-body scanners, are very large and expensive, and consume large amounts of energy as well. A portable T-ray scanning device could in the future make a medical tricorder possible, as T-rays can detect certain biological processes, such as changes in blood flow. As every molecule has a unique signature in the THz range, T-rays can sense for specific molecules as well.

The innovation of this new technology lies in a new nano-antenna integrated into a semiconductor chip that can create much stronger THz fields and lead to higher resolution imaging.

Some details from the announcement:

“…the researchers demonstrated that it is possible to produce a strong beam of T-rays by shining light of differing wavelengths on a pair of electrodes – two pointed strips of metal separated by a 100 nanometre gap on top of a semiconductor wafer. The structure of the tip-to-tip nano-sized gap electrode greatly enhances the THz field and acts like a nano-antenna to amplify the wave generated. In this method, THz waves are produced by an interaction between the electromagnetic waves of the light pulses and a powerful current passing between the semiconductor electrodes. The scientists are able to tune the wavelength of the T-rays to create a beam that is useable in the scanning technology….”

Source : http://www3.imperial.ac.uk/newsandeventspggrp/imperialcollege/newssummary/news_20-1-2012-15-50-15

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Spiro PD Personal Spirometer for Lung Function Analysis

Spiro PD Personal Spirometer for Lung Function Analysis

Spiro PD Personal Spirometer for Lung Function Analysis

(HealthNewsDigest.com) – ALLENTOWN, PENNSYLVANIA, — PMD Healthcare Inc., announced today the launch and availability of its novel new lung health monitoring device – Spiro PD. Recently cleared by the U.S. Food and Drug Administration (FDA), Spiro PD is the first and only personal spirometer that enables patients with lung diseases – those with asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and lung transplants – to easily and accurately monitor their lung function any time and anywhere.

As the first and only personal spirometer, the easy-to-use device is designed specifically to monitor lung function of an adult, adolescent or young child. Other features of Spiro PD allow patients to view their lung function trends over time, manage medications, set reminder alarms to take medicine, do breathing exercises and quickly upload data to their computer and share it with their doctor.

“With the increase in prevalence of emergency room visits and hospitalizations for asthma and other pulmonary problems in the U.S., the availability of Spiro PD is especially significant,” explained Dr. Michael S. Blaiss, a member of the Board of Directors of the World Allergy Organization and a Clinical Professor of Pediatrics and Medicine, University of Tennessee Health Sciences Center in Memphis. “This new device allows patients and parents of young children with lung diseases to know exactly how their condition is doing at any time, enabling patients to have a more active role in controlling their lung health, and potentially identifying problems before the need for costly emergency treatment.”

Lung, or pulmonary, disease is any disease or disorder that occurs in the lungs or that causes the lungs to not work properly1. Regular measurement and monitoring of lung function is important to pulmonary disease management.

“We are excited about the launch of Spiro PD, as we were able to utilize the latest electronic technology to provide patients with lung diseases with an easy-to-use device that conveniently allows them to monitor their lung function anytime and anywhere,” said Wayne Meng, Founder, Chief Executive Officer and President of PMD Healthcare, Inc. “We are confident that this innovative, portable and affordable personal spirometer will empower patients to better control their disease, by enhancing medication adherence, improving communication between doctor and patient and avoiding expensive ER trips and hospital stays.”

About the Spiro PD

The Spiro PD (“Spiro” stands for spirometer, a device used to measure the volume and flow of air entering and leaving the lungs2 and “PD” stands for personal device), is the first personal spirometer that enables patients with lung diseases – those with asthma, COPD, CF and lung transplants – to easily and accurately monitor their lung function anytime and anywhere. Spiro PD allows patients to view their lung function trends over time, manage medications, set alarms reminding them to take medicine, do breathing exercises and quickly upload data to their computer and share it with their doctor.

Spiro PD is cleared to market by the FDA for the use by a patient to test lung function in children, adolescents and adults. It is a single-patient device. Spiro PD is also certified with the CE mark for the European Union (EU) market. Spiro PD meets American Thoracic Society (ATS) and European Respiratory Society (ERS) standards.

Spiro PD is available online with a prescription. Spiro PD is designed and marketed by PMD Healthcare, Inc. For more information visit www.spiropd.com.

About Lung Disease

Lung, or pulmonary, disease is any disease or disorder that occurs in the lungs or that causes the lungs to not work properly1. One example is COPD, the number three cause of death in the U.S. according to the Centers for Disease Control and Prevention (CDC)3. Regular measurement and monitoring of lung function is important to pulmonary disease management, including:

· Asthma is a chronic lung disease that inflames and narrows the airways and can be a life-threatening illness if not properly managed4. An estimated 25 million Americans, including nearly 7 million children, are currently living with asthma5,6. Annually, asthma accounts for approximately 17 million doctor office visits, including physician offices, hospital outpatient and emergency departments7, 10 million missed work days and 13 million missed school days8.

· Chronic Obstructive Pulmonary Disease (COPD), which includes chronic bronchitis and emphysema, is a progressive lung disease that obstructs the airway or damages the small air sacs in the lungs. These changes restrict airflow into and out of the lungs and result in breathing difficulty. More than 12 million Americans are estimated to have COPD, and an estimated additional 12 million adults are undiagnosed3.

· Cystic fibrosis (CF) is a fatal, inherited chronic disease that causes severe lung damage and nutritional deficiencies. Approximately 30,000 children and adults in the U.S. are living with this disease and more than 10 million Americans are carriers of the CF gene. About 1,000 new cases of CF are diagnosed each year9.

· Lung transplant involves a surgical procedure in which a patient’s diseased lungs are partially or totally replaced by lungs from a donor. It is usually used as a last resort for lung failure10.

About PMD Healthcare, Inc.

PMD Healthcare, Inc., headquartered in Allentown, Pennsylvania, is dedicated to creating innovative, easy-to-use, portable and affordable personal medical devices, and to empower people worldwide to improve their healthcare and quality of life. For more information about PMD Healthcare, Inc. visit www.personalmedicaldevices.com.

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References

1. American Lung Association. Lung Disease. http://www.lungusa.org/lung-disease/. Accessed January 2012.

2. American Lung Association. Tools for Identifying & Diagnosing Patients at Risk for COPD. http://www.lungusa.org/associations/states/iowa/events-programs/ia-copd-coalition/ia-copd-assets/tools-for-identifying.pdf. Accessed January 2012.

3. American Lung Association. Understanding COPD. http://www.lungusa.org/lung-disease/copd/about-copd/understanding-copd.html. Accessed January 2012.

4. American Lung Association. Understanding Asthma. http://www.lungusa.org/lung-disease/asthma/about-asthma/understanding-asthma.html. Accessed January 2012.

5. National Heart Lung and Blood Institute. What is Asthma?. http://www.nhlbi.nih.gov/health/prof/lung/asthma/naci/asthma-info/index.htm. Accessed January 2012.

6. Centers for Disease Control and Prevention. Asthma Prevalence, Health Care Use, and Mortality: United States, 2005-2009. http://www.cdc.gov/nchs/data/nhsr/nhsr032.pdf. Accessed January 2012.

7. Centers for Disease Control and Prevention. Asthma: FastStats. http://www.cdc.gov/nchs/fastats/asthma.htm. Accessed January 2012.

8. National Heart Lung and Blood Institute. National Asthma Control Initiative. http://www.nhlbi.nih.gov/health/prof/lung/asthma/naci/pubs/naci-factsheet.pdf. Accessed January 2012.

9. American Lung Association. Understanding Cystic Fibrosis. http://www.lungusa.org/lung-disease/cystic-fibrosis/understanding-cystic-fibrosis.html. Accessed January 2012.

10. National Heart Lung and Blood Institute. What is a Lung Transplant?. http://www.nhlbi.nih.gov/health/health-topics/topics/lungtxp/. Accessed January 2012.

Spiro PD is the world’s first truly personal spirometer. It empowers patients with lung diseases – those with asthma, COPD (including emphysema and chronic bronchitis), CF and lung transplants – to easily, accurately, and affordably monitor their lung function anytime and anywhere at home, at work, at school, at play or while traveling.

Spiro PD can track your lung function trends and alert you of a decline in lung function before you begin to feel symptoms. This helps you anticipate and prevent exacerbations and asthma attacks, and reduce expensive emergency room visits and hospital stays.

Spiro PD enhances medication adherence by enabling you to manage your medications, view your medication history, and set alarms reminding you when to take your medicine, test your lung function, and do breathing exercises. You can also quickly upload lung function data to share with your doctor.

Source : http://www.healthnewsdigest.com/news/Health_Tips_620/

www.PMD_Healthcare_Launches_Spiro_PD_The_First_Personal_Spirometer_To_Monitor_Lung_Function.shtml

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