Archive for September 11th, 2012

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Tandem t:slim Touchscreen Insulin Pump Now On Sale

Tandem t:slim Touchscreen Insulin Pump Now On Sale

Tandem t:slim Touchscreen Insulin Pump Now On Sale

PHILADELPHIA, June 8, 2012 —Tandem Diabetes Care™, Inc. (“Tandem”) announced today at the 72nd Scientific Sessions of the American Diabetes Association that it will begin accepting orders for the t:slim™ Insulin Delivery System, the first insulin pump approved by the FDA with a touch screen, on Monday, June 11, 2012. The product will begin shipping in August 2012.

“Since the t:slim Insulin Delivery System received FDA clearance, we have been conducting user evaluations to further demonstrate its performance and reliability, as well as the readiness of our team,” said Kim Blickenstaff, CEO, Tandem Diabetes Care. “t:slim is proving to be to be easy to teach, easy to learn, and easy to use, and our 24/7 Customer Technical Support Team is also finding it easy to support.”

People interested in the t:slim Insulin Delivery System can begin the order process starting at 6:00am PDT on June 11, 2012. More information is available online at, or by calling 1-877-801-6901. Tandem’s Customer Sales Support Team is available Monday through Friday from 6:00am to 6:00pm PDT to accept orders.

The t:slim Insulin Pump has the footprint of a credit card and the look of a smart phone. Currently the smallest FDA-cleared insulin delivery system, t:slim is up to 25% slimmer than other 300 unit pumps. Unlike other insulin pumps that have complex menus and require excessive button pressing, t:slim’s vivid, color touch screen is the window to an easy-to-use interface that places everything at the touch of a finger.

About Tandem Diabetes Care, Inc.

Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc. ( is a privately held company with novel diabetes technologies. The Company offers a comprehensive, user-centric and integrated approach to product development and customer care. Tandem Diabetes Care is based in San Diego, California.

You can probably guess how I feel about the new Tandem t:slim insulin pump – I want one…now. I first heard of the Tandem at a Children with Diabetes Friends For Life conference, and have hung on to my past-warranty Deltec Cozmo pump until the t:slim hit the streets.

Recently I attended two events where I was able to push the buttons on the t:slim and learn about the technology inside it. I have not had a loaner, so my opinions in this blog post are based on spending 15 minutes looking at the various screens and listening to a presentation from a Tandem representative. This week @TandemDiabetes tweeted that they’ll have a booth at the 2012 ADA scientific sessions that are happening this week (June 6–8) in Philadelphia.

At 3.1 by 2.0 inches the t:slim pump is about the same front size as the Deltec Cozmo and Minimed pumps, but a good deal thinner (0.6 inches). It’s

Tandem t:slim lock screen

metallic with lovely curved edges and really looks like it was designed by Apple. The touch screen is large, bright and colorful. It tried using it under some bright sunlight and it was very easy to read. The capacitive touch screen technology is the same as iPhones, so it works with your fingertip or a stylus pen.

You don’t have to worry about putting it in your pocket and setting it off by accident. The picture on the right shows the lock screen. You have to push buttons 1, 2, and 3 in order before you can start to do anything with the pump. The screen also shows a lot more information: insulin on board; insulin time remaining; reservoir levels and date and time. As you can see the buttons are large and easy to press, this is true on all of the screens. I believe that the insulin on board calculations include insulin from all previous boluses.

After unlocking the t:slim, the center part of the screen changes to give you two choices: Bolus or

Options. (Photo courtesy of Tandem). The choices for Extended Bolus or Split Bolus are built into the sequence for bolusing. So there are less menus throughout the system, with more button presses.

The bolus screen also has two choices, enter the amount of carbs or a blood glucose reading. The large buttons lead you to a screen where you can enter numeric values. After each you return to this screen, where the calculated bolus is displayed. There’s no food database, in the pump. I’d guess that’s due to memory constraints and the challenges of developing an easy to use interface that would let you choose foods and quantities.

What if you didn’t mean to hit the Bolus button? No problem: the Tandem T icon to the right of the screen is also touch sensitive. You can press it at any time and the main Bolus/Options screen will appear. There’s no need for a cancel button.

Tandem has replaced the classic, round, insulin reservoir with a new one that’s rectangular. The t:slim doesn’t have a large motor to push the reservoir plunger, it uses a completely different technology to draw insulin out of the reservoir in micro doses and then push it into the tubing. The picture shows the reservoir set, it has a standard Luer lock that supports most infusion sets.

This slide is from the presentation I attended. It gives some details on the micro-delivery approach that the t:slim uses.

The t:slim specifications are impressive: bolus between 0.05u and 25 u; quick bolus in units or carbs; extended bolus of 15 minutes to 8 hours; insulin duration 2-8 hours in 1-minute increments; tiny basal rate increments; max basal rate of 15u/hour; up to 6 personal profiles; carb ration of 1 to 300 grams per unit; correction factor of 600 mg/dL to 1 mg/dL per unit. Different sounds and alarms. The alarms sounds escalate, so they’re a lot harder to miss.

The site reminder can only be set to a maximum of three days, that’s probably an FDA-imposed limit. The t:slim also supports alarms and reminders. The 25u bolus limitation was imposed by the FDA. You can enter a higher number of units; after the t:slim has delivered 25u it’ll prompt you and ask you to confirm that you want to deliver the remainder.

No more batteries! The t:slim has a rechargeable lithium polymer battery that’s recharged via a standard micro-USB port. They claim it last about 7 days when fully charged. This type of battery does well when charged for a set amount of time each day, and the pump can be worn while the battery is charging.

One last screen. Whatever time-related setting you want to change – insulin/carb ratios; basal rates; insulin correction factor – there’s only a single screen. This also makes it much easier to show the current settings to your healthcare team.

I didn’t see the related software. I don’t know whether it will be available on Mac computers.

As a software designer and a person with diabetes, I’m really impressed by the quality of the screens and how easy it is to use. I think this will really push other pump makers to make their pumps much easier to use.

My only real complaint (and it’s small). I think the t:slim only comes in Model T black. Perhaps the colorful screens make up for that.

If I do manage to get a loaner unit, I’ll put up another post with some video. Happy summer all.

Tandem Diabetes Care out of San Diego, CA will soon be marketing in the U.S. its t:slim insulin pump thanks to a newly issued FDA approval. zmgv0oc31 Tandem t:slim Insulin Pump Gets FDA ClearanceThe t:slim looks more like an iPhone 4 than a critical medical device, including a color touchscreen and USB connectivity for syncing with a computer and for recharging the internal battery.

This may not be a coincidence because the rep for Tandem, in an email to Medgadget, specifically mentioned Amy Tenderich’s open letter to Steve Jobs calling for Apple to design an insulin pump from four years ago. We think Amy should take at least a bit of credit for encouraging such a stunning design.

The slide-out insulin cartridge is easy to change and the device can connect to PC’s and Macs to upload pump data to a web-based application for further review.

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Endosense’s TactiCath Quartz Force Sensing Cardiac Ablation Cath Now Available in Europe

Endosense’s TactiCath Quartz Force Sensing Cardiac Ablation Cath Now Available in Europe

Endosense’s TactiCath Quartz Force Sensing Cardiac Ablation Cath Now Available in Europe

GENEVA–(BUSINESS WIRE)–Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced that its TactiCath Quartz force-sensing ablation catheter has been CE mark approved. In cooperation with the company’s distributor BIOTRONIK, first cases using the new device have been performed by renowned physicians at three centers across Europe: Dr. Dipen Shah from University Hospital of Geneva; Dr. Georg Nölker from Heart and Diabetes Center in Bad Oeynhausen, Germany; and, Dr. Reza Wakili and Dr. Heidi Estner from University Hospital Grosshadern in Munich.

“As a long-time user of the TactiCath, I find the Quartz generation to be another significant improvement in the field”

The TactiCath Quartz is a third generation device that brings a host of technical and practical advancements to the electrophysiology lab. Key innovations include a new force sensor that provides increased stability and precision and avoids the need for pre-procedure calibration; a significantly smaller equipment footprint; a user friendly graphical interface; and, enhanced signal processing and digital output that facilitates connectivity with imaging devices and other equipment in the lab.

“As a long-time user of the TactiCath, I find the Quartz generation to be another significant improvement in the field,” said Dr. Shah. “The new force sensor technology gives me even greater confidence in the accuracy of the force signal. In addition, the 50Hz sampling rate dramatically increases precision of the display and gives me every detail of the force applied in real time.”

Also new to the TactiCath Quartz is a breakthrough Lesion Index (LSI) parameter that provides an improved, real-time indication of lesion quality during catheter ablation procedures. Pioneered by Endosense, LSI is a sophisticated algorithm that correlates lesion formation with radiofrequency power, ablation time and contact force. Clinical data presented at Heart Rhythm 2012 showed that LSI is so far the best available parameter to predict risk for reconnection after pulmonary vein isolation (PVI), with high statistical significance. The LSI will be available in addition to the already widely recognized FTI (Force Time Integral) feature, also developed by Endosense.

“The TactiCath Quartz is an innovation born from more than two years of extensive commercial experience with earlier TactiCath devices,” said Jan Keltjens, Endosense president and chief executive officer. “We believe this third generation device will consolidate our leadership position and that LSI will set the new standard in the field. With its greatly enhanced ease of use and performance, the TactiCath Quartz will further advance the strong trend towards force-sensing becoming part of the standard of care.”

The TactiCath Quartz is CE mark approved for the treatment of atrial fibrillation (AF) and supraventricular tachycardia (SVT). The new device and its accompanying TactiSys system are available commercially in Europe through Endosense’s distribution partner BIOTRONIK.


As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

About Endosense

Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of contact-force measurement in catheter ablation with the development of the TactiCath, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Endosense is backed by Edmond de Rothschild Investment Partners, Neomed, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners and Initiative Capital Romandie. For more information, visit

Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

Endosense (Geneva, Switzerland) has announced that its TactiCath Quartz force sensing ablation catheter has been CE marked and is already being used at three European hospitals to treat cardiac arrhythmias.

The new catheter features a new force sensor that doesn’t require to be calibrated before the procedure, an improved interface and the entire equipment package has been shrunk a bit to be more friendly around the OR. The system provides digital output of its status and sensing data for interfacing with other technologies.

From the announcement:

Also new to the TactiCath Quartz is a breakthrough Lesion Index (LSI) parameter that provides an improved, real-time indication of lesion quality during catheter ablation procedures. Pioneered by Endosense, LSI is a sophisticated algorithm that correlates lesion formation with radiofrequency power, ablation time and contact force. Clinical data presented at Heart Rhythm 2012 showed that LSI is so far the best available parameter to predict risk for reconnection after pulmonary vein isolation (PVI), with high statistical significance. The LSI will be available in addition to the already widely recognized FTI (Force Time Integral) feature, also developed by Endosense.

The TactiCath Quartz is CE mark approved for the treatment of atrial fibrillation (AF) and supraventricular tachycardia (SVT). The new device and its accompanying TactiSys system are available commercially in Europe through Endosense’s distribution partner BIOTRONIK.

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MIT Fuel Cell Uses Sugar to Power Neural Implants

MIT Fuel Cell Uses Sugar to Power Neural Implants

MIT Fuel Cell Uses Sugar to Power Neural Implants

MIT engineers have developed a fuel cell that runs on the same sugar that powers human cells: glucose. This glucose fuel cell could be used to drive highly efficient brain implants of the future, which could help paralyzed patients move their arms and legs again.

The fuel cell, described in the June 12 edition of the journal PLoS ONE, strips electrons from glucose molecules to create a small electric current. The researchers, led by Rahul Sarpeshkar, an associate professor of electrical engineering and computer science at MIT, fabricated the fuel cell on a silicon chip, allowing it to be integrated with other circuits that would be needed for a brain implant.

The idea of a glucose fuel cell is not new: In the 1970s, scientists showed they could power a pacemaker with a glucose fuel cell, but the idea was abandoned in favor of lithium-ion batteries, which could provide significantly more power per unit area than glucose fuel cells. These glucose fuel cells also utilized enzymes that proved to be impractical for long-term implantation in the body, since they eventually ceased to function efficiently.

The new twist to the MIT fuel cell described in PLoS ONE is that it is fabricated from silicon, using the same technology used to make semiconductor electronic chips. The fuel cell has no biological components: It consists of a platinum catalyst that strips electrons from glucose, mimicking the activity of cellular enzymes that break down glucose to generate ATP, the cell’s energy currency. (Platinum has a proven record of long-term biocompatibility within the body.) So far, the fuel cell can generate up to hundreds of microwatts — enough to power an ultra-low-power and clinically useful neural implant.

“It will be a few more years into the future before you see people with spinal-cord injuries receive such implantable systems in the context of standard medical care, but those are the sorts of devices you could envision powering from a glucose-based fuel cell,” says Benjamin Rapoport, a former graduate student in the Sarpeshkar lab and the first author on the new MIT study.

Rapoport calculated that in theory, the glucose fuel cell could get all the sugar it needs from the cerebrospinal fluid (CSF) that bathes the brain and protects it from banging into the skull. There are very few cells in the CSF, so it’s highly unlikely that an implant located there would provoke an immune response. There is also significant glucose in the CSF, which does not generally get used by the body. Since only a small fraction of the available power is utilized by the glucose fuel cell, the impact on the brain’s function would likely be small.

Karim Oweiss, an associate professor of electrical engineering, computer science and neuroscience at Michigan State University, says the work is a good step toward developing implantable medical devices that don’t require external power sources.

“It’s a proof of concept that they can generate enough power to meet the requirements,” says Oweiss, adding that the next step will be to demonstrate that it can work in a living animal.

A team of researchers at Brown University, Massachusetts General Hospital and other institutions recently demonstrated that paralyzed patients could use a brain-machine interface to move a robotic arm; those implants have to be plugged into a wall outlet.

Mimicking biology with microelectronics

Sarpeshkar’s group is a leader in the field of ultra-low-power electronics, having pioneered such designs for cochlear implants and brain implants. “The glucose fuel cell, when combined with such ultra-low-power electronics, can enable brain implants or other implants to be completely self-powered,” says Sarpeshkar, author of the book “Ultra Low Power Bioelectronics.” This book discusses how the combination of ultra-low-power and energy-harvesting design can enable self-powered devices for medical, bio-inspired and portable applications.

Sarpeshkar’s group has worked on all aspects of implantable brain-machine interfaces and neural prosthetics, including recording from nerves, stimulating nerves, decoding nerve signals and communicating wirelessly with implants. One such neural prosthetic is designed to record electrical activity from hundreds of neurons in the brain’s motor cortex, which is responsible for controlling movement. That data is amplified and converted into a digital signal so that computers — or in the Sarpeshkar team’s work, brain-implanted microchips — can analyze it and determine which patterns of brain activity produce movement.

The fabrication of the glucose fuel cell was done in collaboration with Jakub Kedzierski at MIT’s Lincoln Laboratory. “This collaboration with Lincoln Lab helped make a long-term goal of mine — to create glucose-powered bioelectronics — a reality,” Sarpeshkar says. Although he has just begun working on bringing ultra-low-power and medical technology to market, he cautions that glucose-powered implantable medical devices are still many years away.

We have developed an implantable fuel cell that generates power through glucose oxidation, producing steady-state power and up to peak power. The fuel cell is manufactured using a novel approach, employing semiconductor fabrication techniques, and is therefore well suited for manufacture together with integrated circuits on a single silicon wafer. Thus, it can help enable implantable microelectronic systems with long-lifetime power sources that harvest energy from their surrounds. The fuel reactions are mediated by robust, solid state catalysts. Glucose is oxidized at the nanostructured surface of an activated platinum anode. Oxygen is reduced to water at the surface of a self-assembled network of single-walled carbon nanotubes, embedded in a Nafion film that forms the cathode and is exposed to the biological environment. The catalytic electrodes are separated by a Nafion membrane. The availability of fuel cell reactants, oxygen and glucose, only as a mixture in the physiologic environment, has traditionally posed a design challenge: Net current production requires oxidation and reduction to occur separately and selectively at the anode and cathode, respectively, to prevent electrochemical short circuits. Our fuel cell is configured in a half-open geometry that shields the anode while exposing the cathode, resulting in an oxygen gradient that strongly favors oxygen reduction at the cathode. Glucose reaches the shielded anode by diffusing through the nanotube mesh, which does not catalyze glucose oxidation, and the Nafion layers, which are permeable to small neutral and cationic species. We demonstrate computationally that the natural recirculation of cerebrospinal fluid around the human brain theoretically permits glucose energy harvesting at a rate on the order of at least 1 mW with no adverse physiologic effects. Low-power brain–machine interfaces can thus potentially benefit from having their implanted units powered or recharged by glucose fuel cells.

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Dengue vaccine breakthrough

Dengue vaccine breakthrough

Results of the first ever trial to show that a safe and effective dengue vaccine may be possible are published Online First in The Lancet.

Dengue is one of the most widespread mosquito-borne viral diseases in the world, with WHO estimating that around half of the world’s population are currently at risk. While infection usually causes flu-like symptoms, it can develop into a more serious form of the disease, known as severe dengue, which is a leading cause of severe illness and death among children in some Asian and Latin American countries. The incidence of dengue appears to have grown dramatically in recent decades – before 1970 only nine countries had experienced severe dengue epidemics, but the disease is now thought to be endemic in more than 100 countries across the world.

There is currently no vaccine to protect against dengue, and efforts to develop one have been hampered by the fact that dengue is not caused by a single virus, but rather four different related viruses (known as DENV 1, 2, 3 and 4), making development of an effective vaccine considerably more complicated than for some viral diseases. Furthermore, the disease appears to be unique to humans, meaning that scientists cannot use animal models to test prospective vaccine candidates.

Several possible dengue vaccine candidates are currently in development, but the new results are the first to be published showing that an effective and safe dengue vaccine may be possible. Researchers based in France and Thailand tested the effectiveness of a vaccine candidate called CYD-TDV on a group of 4002 schoolchildren in Thailand, aged from four to eleven years old. The trial took place in Thailand because dengue is known to be endemic in this area, and local residents have a good awareness of the disease and its symptoms.

2669 children were given the CYD-TDV vaccine, and 1333 given a placebo. Overall, there was no statistically significant difference between the number of dengue cases recorded in the vaccine (76 cases or 2.8% of the vaccine group) and control groups (58 cases or 4.4% of the control group). However, secondary tests showed that the vaccine was effective against DENV 1, 3 and 4 (in the range of 60 to 90%), with only DENV 2 appearing to be resistant to the effects of the vaccine in this trial. Furthermore, CYD-TDV appears to be safe and well-tolerated, with no vaccine-related serious adverse events being reported in the group who received it.

While the scientists point out that the phase 2b trial is limited by the fact that it was conducted in a single geographical area, the results nonetheless represent a substantial advance in the development of a vaccine for dengue. According to co-author Dr Derek Wallace of Sanofi Pasteur, the company which developed the vaccine, “Our study constitutes the first ever demonstration that a safe and effective dengue vaccine is possible. Further trials of CYD-TDV are currently underway in a number of different countries, and our hope is that the positive results of this trial will be confirmed by these larger studies, taking place in a wide range of epidemiological settings. Nearly half a million people are thought to be hospitalised with dengue every year, the majority of which are children, so the development of a safe and effective vaccine has the potential to make a hugely positive impact.”

In a linked Comment, Dr Scott Halstead, of the International Vaccine Institute in Seoul, said: “Results from this vaccine trial provide hard evidence of protection against DENV 1, 3 and 4 mild disease but insufficient data to calculate vaccine efficacy rates for severe disease. Future dengue vaccine trials should provide robust evidence of efficacy against severe disease by selecting populations weighted to assure inclusion of sufficient numbers of at risk children.”

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DATATRAK announces technology and services agreement with Bellicum

DATATRAK announces technology and services agreement with Bellicum

DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a multi-million dollar, five-year technology and services agreement with Bellicum Pharmaceuticals.

DATATRAK worked with Bellicum to design a combined technology and services offering to assist in the progression of their oncology products throughout the FDA clinical trial process. As a biotherapeutics company, Bellicum needs to control data collection and management costs for their biological drug products from development through commercialization. The DATATRAK Enterprise pricing model and DATATRAK Clinical and Consulting Services’ (DCCS) expertise were the ideal solution for Bellicum. The DATATRAK Enterprise pricing model allowed Bellicum to project their costs over the five year period of clinical trial execution, and with DCCS providing a full suite of professional services, Bellicum enjoys a single source vendor for their data needs.

“We are pleased to collaborate with DATATRAK on our clinical trial programs,” said Tom Farrell, CEO of Bellicum. “This partnership will enable us to advance our two lead clinical development programs for patients with prostate cancer and patients undergoing a hematopoietic stem cell transplant.”

“We are very excited about our new relationship with Bellicum,” stated Laurence P. Birch, DATATRAK’s Chairman of the Board and CEO. “As biotechs are vital contributors in bringing new drugs to market and improving quality of life, we are happy to play a small part in the development of their new products.”

The DATATRAK ONE™ Clinical Research Platform is an easy to use, cloud-based clinical enterprise solution that empowers Sponsors and CROs to efficiently design, deliver and manage clinical trials. From strategy and planning to resource management and study execution needs, clients manage their entire product portfolio in a single system with one username and password. DATATRAK’s unified clinical enterprise solution consists of seven products: uCTMS, uDesign, uEDC, uIRT, uSafety, uTrain and uCDR.

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FDA clears Covidien’s LigaSure technology for ENT procedures

FDA clears Covidien’s LigaSure technology for ENT procedures

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures. When working in confined surgical spaces, the proprietary LigaSure device addresses surgeons’ needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues.

The new clearance, for the device’s use in head and neck procedures, will allow for additional uses such as thyroidectomies, parotidectomies and additional open ENT procedures. There are more than 160,000 of these procedures performed each year in the United States. The LigaSure small jaw instrument, sold worldwide, was previously cleared for use in general surgery by the FDA in February 2011.

“This is a major milestone in recognizing the LigaSure small jaw instrument as an effective open surgical device and significantly expands its use throughout the surgical community. We believe surgeons will see it as a valuable tool for ENT procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “LigaSure technology has set the industry standard in vessel sealing since 1998. This technology has been used in millions of surgical procedures worldwide and is supported by an every growing body of evidence-based research.”

LigaSure’s features received positive comments from surgeons during development as well as post-commercialization. “I confidently placed my finger immediately adjacent to the tips while sealing without feeling any significant heat,” said Dr. Thomas P. Rauth, a surgeon at Vanderbilt University Medical Center. “The importance of this cannot be stressed enough.” He also praised the device’s functionality, stating that “the ergonomics of the device are outstanding. The hand activation with the closing of the instrument is a simple, yet brilliant, concept. It sped up the operation since I didn’t have to search for a foot control or second button to activate the current.1″

The LigaSure small jaw instrument provides an integrated cutting mechanism independent of sealing, leaving critical cutting decisions in the surgeon’s hands. Its multifunctional design also provides for blunt dissection and an enhanced experience for the surgeon, especially in confined surgical spaces. LigaSure technology, powered by the ForceTriad™ energy platform, gives surgeons a continuous output of energy, monitoring the tissue and making real-time adjustments 3,333 times/second to seal vessel walls.

The product will be showcased this year at the American College of Surgeons Annual Clinical Congress, to be held September 30 – October 4 in Chicago, IL. Surgeons are invited to booth 1819 to further explore the benefits of the LigaSure small jaw instrument.

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GE Healthcare announces data from [18F]flutemetamol phase III studies on Alzheimer’s

GE Healthcare announces data from [18F]flutemetamol phase III studies on Alzheimer’s

GE Healthcare today announced pooled results from phase III brain autopsy and biopsy studies on the investigational PET amyloid imaging agent, [18F]flutemetamol, which showed a strong concordance between [18F]flutemetamol images and Alzheimer’s disease-associated beta amyloid brain pathology. [18F]Flutemetamol is a PET imaging agent being developed by GE Healthcare for the detection of beta amyloid deposits in the brain. The data from the phase III studies further confirm the potential application of [18F]flutemetamol as an imaging agent to detect beta amyloid plaques.

The data was presented at the 16th Congress of the European Federation of Neurological Societies (EFNS) in Stockholm, Sweden, and provide support for an application for regulatory approval of [18F]flutemetamol, which is intended to be filed in the US and EU later this year.

“We are encouraged that [18F]flutemetamol PET images accurately and consistently reflected beta amyloid levels in living patients,” said Ville Leinonen, MD, PhD, board certified Neurosurgeon and Director of Kuopio University Hospital NPH Group, Kuopio, Finland. “Currently, Alzheimer’s disease is confirmed during autopsy studies, but if we can detect beta amyloid earlier, we can help physicians make a more timely clinical diagnosis that can impact disease management and treatment decisions.”

The clinical development program examined a number of subjects including 180 end-of-life subjects (69 of whom were followed to autopsy) and 49 subjects with suspected Normal Pressure Hydrocephalus (NPH) – a progressive condition associated with dementia, gait abnormalities and urinary incontinence – who underwent in vivo cortical biopsy. All participants received [18F]flutemetamol injection. Beta amyloid was evaluated using Bielschowsky silver stain and/or the beta amyloid peptide specific antibody – 4G8. The PET images were then read by trained physicians, who identified the images as normal or abnormal.

For patients from the four separate biopsy studies [18F]flutemetamol detected beta amyloid with a median sensitivity ranging from 75-100 percent and specificity ranging from 99-100 percent. A similar range was also found for autopsied subjects. Further, the visual assessment of all images showed a high level of agreement among readers.

The accumulation of beta amyloid in the brain is believed to play a role in the degeneration of neurons in AD and is one of several pathological characteristics implicated in the development of AD. Currently, AD is confirmed by histopathological identification of core features, including beta amyloid plaques, in post-mortem brain samples. Targeted amyloid imaging agents are being studied to determine their ability to help physicians detect amyloid deposition in living humans.

“We know that Alzheimer’s disease-related biomarkers such as beta amyloid may appear decades before clinical symptoms are observed, and the results from these studies demonstrate the potential of [18F]flutemetamol to detect such biomarkers in living patients,” said Jonathan Allis, General Manager, PET, GE Healthcare Medical Diagnostics. “These study results and the recently updated EFNS guidelines on the use of neuroimaging for the diagnosis of dementia, which back the clinical utility of amyloid imaging in the evaluation of AD under certain conditions, further support the potential regulatory approval of [18F]flutemetamol, and we look forward to filing for regulatory approval later this year in the US and EU.”

[18F]Flutemetamol is one component of a broad portfolio of diagnostic solutions that GE Healthcare is currently developing in the Alzheimer’s field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. For example, the company is partnering with the pharmaceutical industry to identify a biosignature – or biological indicator – may help physicians diagnose AD before the onset of clinical symptoms.

GE Healthcare offers a broad portfolio of imaging resources that support accurate visualization of the signs of neurodegenerative diseases via state-of-the-art scanners – including MRI, PET, and CT – that deliver clear visualization of the brain. In addition, an expanding portfolio of imaging agents is being developed to enhance visual evidence of disease and innovative software applications to aid physicians in image interpretation and determination of disease management. More specifically, its portfolio today includes cyclotrons and chemistry systems to manufacture PET imaging agents, PET and MR scanners to scan patients, and image analysis software to interpret the results.

GE Healthcare has been a key contributor to the Alzheimer’s Disease Neuroimaging Initiative (ADNI) since its inception. GE Healthcare also plays a key role in PredictAD, an EU-funded research project to develop solutions to enable earlier diagnosis of AD, and in the Coalition Against Major Diseases (CAMD).

Additionally, the combination of different business offerings positions GE Healthcare in a good position to offer an integrated global diagnostics solution to assist the pharmaceutical industry in its development of the next generation of therapies. To that end, it is working with potential partners in the industry to understand their strategic needs and design solutions, and help provide imaging support for pivotal therapy trials.

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Pfizer, Visterra collaborate to discover novel antibodies

Pfizer, Visterra collaborate to discover novel antibodies

Visterra Inc., developer of novel therapeutics to treat major diseases, announced today that it has entered into a collaboration agreement with Pfizer to discover novel antibodies using Visterra’s proprietary platform.

Under the terms of the agreement, Visterra will receive an up-front fee as well as research funding, and is eligible to receive predetermined payments for meeting certain research and development milestones, plus royalties upon any product commercialization.

“We are very pleased that our first pharmaceutical partnership is with Pfizer, an industry leader with broad drug development expertise,” said Steven Brugger, CEO of Visterra. “This collaboration further supports the potential utility of Visterra’s antibody design platform, and we look forward to collaborating with Pfizer while we continue to advance Visterra’s own internal product pipeline.”

“We view Visterra’s technology as a promising approach for engineering therapeutic antibodies, and look forward to this collaboration” said Jose-Carlos Gutierrez-Ramos, Senior Vice President, Research and Development, Biotherapeutics with Pfizer.

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Ghost Smart Sensor Glove Coaches Blind Athletes

Ghost Smart Sensor Glove Coaches Blind Athletes

Ghost Smart Sensor Glove Coaches Blind Athletes

(—An engineering team from Imperial College London have come up with a vibrating armband tagged Ghost that can train a person’s muscles and teach the user how to swing like Nadal, or play golf like Tiger, or help improve moves in other sports. The vibrating device, in prototype stage, is called Ghost because it can copy another person’s movement. The user can download the movements of Wimbledon tennis players, for example, and the device will teach the user how to copy the stars’ movements. Arm motion can be digitally recorded from the player of choice, and that arm motion is uploaded to the armband from the computer. Ads by Google Fitness & Spa Equipment – Design, Supply, Train & Maintain Technogym, GeoSpa, Unbeschieden – Through “muscle memory” the player, in a tennis practice scenario, can attempt to repeat the serve. “Muscle memory” is when sports players are able to perform a precise movement unconsciously after repeatedly practicing the same task. The hand and armband device uses vibrating pads and sensors to fine-tune arms into carrying out the preplanned movements. Benedict Copping, an engineer at Imperial College London and the Royal College of Art and the team leader, said: “A coach can set a series of way points that the wearer has to move through and the device tells them if they are hitting them by vibrating as they move.” The Ghost has an array of sensors that detect the twisting and flexing of a person’s joints. LED lights tell the user of stroke accuracy. Vibrators help guide the path of the arm. This video is not supported by your browser at this time. The vibrating armband originated, though, as not something for aspiring Wimbledon stars but as an assistive device to teach blind athletes how to swim. “Ghost: A Paralympic Trainer” was purposed as a wearable coaching aid that would give feedback when certain moves were correctly executed. The designer team noted that it is vision that allows people in sports to imitate and refine muscular movements. Those with severe visual impairments find it difficult to correct complex motion skills. The Ghost team noted how swimmers practice to refine and polish their stroke mechanics, and vision allows sighted swimmers to imitate and refine muscular movements. Having a severe visual impairment can make it difficult to correct and perfect complex motion skills; the visually impaired cannot make use of coaching demos or video analysis techniques, for example. The team’s device provided instant feedback via vibration for constant technique improvement in conjunction with or in the absence of the coach. Feedback of the athlete’s motion was along a predefined pathway, made of a series of gateways memorized by the device and set by the coach, which allowed them to form competitive muscle memories through repetition. The athlete guided motions through these gateways by strong LED indications and vibration at each joint. The device was programmed from an Arduino mini, using off the shelf components. “For people who cannot see very well, this could allow them to practice technique and become really efficient,” said Copping.

The Project

A 3 week group project in collaboration with the London Paralympic Games 2012, Rio Tinto and world class athlete stakeholders such as Jimmy Godard and Iain Dawson.

The Problem

A key problem we identified within our brief was that visually impared or indeed blind athletes having trouble with their kinesthetic movements, basically locating their limbs in space. Currently the only real way to ovecome this is to practice sporting technique, whether it be a swimming stroke, tennis stroke or archery with a personal trainer learning the movement through rote memorisation until becomes part of their muscle memory. This obviously creates a number of problems, key of which is requiring a personal coach in order to train which is very expensive and highly restrictive to an athletes development and indeed the development of new para Olympic talent.

The Insight

Through continuous ideation and fast prototypes we identified that it was possible to guide the body with extreme accuracy using haptic (vibration) based feedback, bypassing the need for full vision.

The Idea & Prototype

So in response to this we developed the ghost system, a device that allows you to train independently of a personal coach freeing the athletes to take control over their development and training. This is achieved by storing the position data for an optimum technique, lets say a swimming stroke, inside the device and guiding the athlete through the technique by providing vibration feed back relative to their accuracy.

The device operates by setting and identifying “waypoints” throughout the technique, which are utilised to guide the athlete through the optimum stroke, pull or launch. For example now a personal trainer can take the athlete through the technique once setting up the device or more efficiently download the metric for an optimum technique on to the device. Once the device is set the athlete begins training and as they move through those waypoints receive vibration feedback relative to their accuracy on hitting those waypoints.

The idea is that with each revolution muscle memory is being earned without the need for an expensive personal trainer. Allowing the athlete to train longer, more efficiently and with better accuracy. As I’m sure any athlete will tell you more training and better training means medals.

The Paralympics are always a reminder of how one physical disability does not define the rest of the person. Quadriplegics can still fire rifles and throw a ball, and blind people can still run, jump, and swim. The difference for blind folks, though, is that athletes learn correct muscle motion by studying the movement of others, and blind people can’t really do that. Trainers usually guide blind athletes by directly moving their arms and legs, helping to embed the movements into their muscle memory.

PhysOrg is profiling the work of researchers at Imperial College London who developed a vibrational feedback device that teaches blind people to perform precise repetitive movements without an ever-present coach. The Ghost system can memorize specific movements when demonstrated by a trainer. The athlete can then repeatedly practice those movements while the Ghost monitors their accuracy and provides guidance using vibrations and audio cues.

Moreover, the system can import motion recordings taken from star athletes, helping the blind reproduce techniques that win medals in the Olympics. Although the system was designed specifically for blind athletes, we expect the technology to find its way to people recovering from a stroke or other neurological conditions.

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SoundBite Dental Hearing System Now an Option in Europe

SoundBite Dental Hearing System Now an Option in Europe

SoundBite Dental Hearing System Now an Option in Europe

The SoundBite™ Hearing System in Detail

SoundBite Hearing System works by making innovative use of the well-established, natural principle of bone conduction – the transmission of imperceptible sound vibrations through the bones to the inner ears – to deliver clear, natural, high quality sound.

Nearly invisible when worn, the SoundBite system consists of two components: an easy to insert and remove ITM (in-the-mouth) hearing device and a small BTE (behind-the-ear) microphone unit worn on the impaired ear. No dental work or modifications to the teeth are required. Both components have rechargeable batteries and a system charger is also provided.

The BTE (Behind-The-Ear) Microphone Unit

SoundBite Behind-the-Ear Unit

BTE (Behind-The-Ear)

Microphone Unit

To take advantage of the natural acoustic benefits provided by the patient’s own ear, sound in the environment is picked up by a tiny microphone placed within an open fit dome worn in the canal of the impaired ear and connected to the BTE by a small translucent tube. The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the ITM hearing device, which in turn sends imperceptible vibrations via the teeth near-simultaneously to both cochleae. In this way, sound is rerouted from the impaired ear directly to the good cochlea – bypassing the middle and outer ear entirely – to effectively restore the perception of hearing from the impaired ear. SoundBite Hearing System delivers sound across a broad frequency range of 500 Hz to more than 12 kHz.

The ITM (In-the-Mouth) Hearing Device

SoundBite Oral Device

ITM (In-The-Mouth)

Hearing Device

The ITM device is custom made to fit around either the upper left or right back teeth, does not require any alteration of the teeth, and is easily inserted and removed by the wearer. It contains electronics, a sealed, flat, rechargeable battery, wireless capability that picks up sound transmissions from the BTE, and a small actuator that converts those signals into vibratory energy. All of these miniaturized components are hermetically sealed inside a dental grade acrylic that has been safely used for making dental appliances for many years.

System Charger

SoundBite Charger

System Charger with


SoundBite does not require changing batteries. A system charger powers both the ITM Hearing Device and BTE microphone unit. The charge lasts 6 to 8 hours for the ITM and 15 to 18 hours for the BTE.

SAN MATEO, Calif., Sept. 5, 2012 /PRNewswire/ — Sonitus Medical, Inc., a medical device company that manufactures the world’s first non-surgical and removable hearing device to transmit sound via the teeth, today is announcing the global commercialization and a limited market launch in Europe of its SoundBite™ Hearing System. The first deployment of its prosthetic devices throughout Europe is a measured roll out to seven centers of excellence in key markets in order to conduct a multi-site evaluation of the SoundBite prosthetic device.

“This is a major milestone for our company as we begin to establish a commercial network for SoundBite in Europe,” said Amir Abolfathi, CEO of Sonitus Medical. “We are gratified to be working with esteemed hearing specialists in the EU medical community to undertake this post-market evaluation which will document long-term utilization and patient experience.”

The SoundBite Hearing System received CE Mark certification in The European Union for the treatment of single sided deafness, or patients who are essentially deaf in one ear, those with conductive hearing loss, and those with mixed hearing loss.

SoundBite uses bone conduction to deliver clear, high quality sound to the inner ear. Many familiar sounds are heard through bone conduction; for example chattering teeth, crunching on potato chips, or scratching the scalp. Nearly invisible when worn, the SoundBite system consists of an easy to insert and remove in-the-mouth hearing device and a small microphone unit worn behind the ear.

About the European Pilot Study

Currently underway with 20 patients at four leading academic medical centers, the pilot study will monitor patient experiences and qualitative results at one, six, and 12 months, and will grow to include five patients at each site for a total of 35 subjects.

The seven participating centers of excellence are: The University Hospital Southampton, United Kingdom; University Hospital Ramon y Cajal, Madrid, Spain; University Hospital, Maastricht, Netherlands; University Hospital of Geneva, Switzerland; University Medical Center of Mainz, Germany; Hanusch Hospital, Vienna, Austria; and ENT Practice of Dr. Waldemar Motzko, Bad Soden, Germany.

New Senior Management

With Sonitus’ European commercialization plans well underway, the company has deepened its management team with the recent appointment of two high level senior executives with decades of relevant experience.

Mike Favet, named Chief Operating Officer, has been in the medical device industry for more than 20 years, accumulating broad cross-functional experience in companies of various sizes with products in diverse therapeutic areas. Chief Financial Officer Jeff Mack brings more than 25 years of experience, including a strong background with fast-growing, technology-based companies. He has extensive experience in all areas of financial management, including capital events/IPOs, SEC reporting and compliance, M&A and investor relations.

“We are extremely pleased to welcome these two seasoned executives to the company,” said Abolfathi. “As we to continue to ramp up our European network, Mr. Favet and Mr. Mack will play integral roles in guiding Sonitus Medical forward in our efforts to offer a novel treatment solution for all patient who suffer from single sided deafness, conductive hearing loss, or mixed hearing loss.”

About Sonitus Medical

Sonitus Medical ( is a privately held medical device company committed to providing advanced hearing solutions that hearing professionals such as otologists, ENTs, and audiologists can use to help their patients rejoin the conversation of life. Founded in June 2006, the company is headquartered in San Mateo, California. Its SoundBite Hearing System ( is the world’s first non-surgical and removable hearing solution that relies on bone conduction to imperceptibly transmit sound via the teeth.

Currently FDA cleared for the treatment of both single sided deafness and conductive hearing loss, SoundBite Hearing System has intended future indications for hearing disorders such as tinnitus. The technology also has application in consumer and communications. Additionally, the company has received its CE Mark certification, which indicates full quality assurance system approval and that Sonitus Medical’s design and manufacturing processes for the SoundBite device comply with certain manufacturing and design standards under the European directive concerning medical devices.

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