3-2-12
New Device Removes Stroke-Causing Blood Clots Better Than Standard TreatmentAn experimental device for removing blood clots in stroke patients dramatically outperformed the standard mechanical treatment, according to research presented by UCLA Stroke Center director Dr. Jeffrey L. Saver at the American Stroke Association's 2012 international conference in New Orleans on Feb. 3. The SOLITAIRE Flow Restoration Device is among an entirely new generation of devices designed to remove blood clots from blocked brain arteries in patients experiencing stroke. It has a self-expanding, stent-like design and, once inserted into a clot using a thin catheter tube, it compresses and traps the clot. The clot is then removed by withdrawing the device, thus reopening the blocked blood vessel.
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2-2-12
How physician innovators can make medical devices more efficientAlthough medical device companies spend large sums of money paying “Key Opinion Leaders” (KOL’s) for their thoughts on the future of medicine and products in specific clinical indications, this should not be mistaken for collaboration.
KOL’s are typically driven by the marketing function within an organization, with larger companies having more specialized strategic marketing resources responsible for coaxing prognostications out of leading clinicians in a field. Whether these doctors provide technically accurate responses is of little consequence since their opinions are assumed to become self-fulfilling prophecies. More... |
Social Innovation: Digital Health is Our FutureDigital health is the hottest growth area in technology and social innovation. According to a study byPew Research, medical and healthcare was the third-fastest-growing category of Smartphone apps and by 2015 nearly 500 million people are expected to be using mobile healthcare apps.This year's International Consumer Electronics Show (CES) debuted products that address the needs of health-conscious populations, particularly advances in medical science targeted at the world's ageing population. The growth in mobile healthcare devices and applications has also inspired Ford, the automobile manufacturer, to integrate healthcare into its vehicles. As being informed about our health while on the go has become a real need.
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1-2-12
Medical technology worth €7.2bn to economy last yearIncreased focus must be placed on developing medical technology research into viable businesses according to Irish Medical Device Association (IMDA). The IMDA today launched its four-year strategy plan for the medical technology sector, which according to the association last year created 875 jobs and contributed €7.2 billion to the Irish economy. The plan focuses on developing a culture of commercialisation in Irish universities and fostering innovation. It is already evident that there are possibilities for Irish companies within the industry as 50% of the 250 medical technology firms based here are indigenous.
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Galien Foundation - 2012 Awards Program For Best Biopharmaceutical Products and Best Medical TechnologyThe 'Prix Galien' Award - Biomedical industry's highest accolade for innovative research & development The Galien Foundation announced today open enrollment for the annual Prix Galien USA Awards to recognize outstanding achievement in improving the human condition through the development of innovative medical treatments and drug therapies. The 2012 awards ceremony will be held on October 16th in New York City. Awards will be bestowed for products in the following categories; Best Pharmaceutical Agent, Best Biotechnology Product, and Best Medical Technology.
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31-1-12
Skin transformed into brain cellsSkin cells have been converted directly into cells which develop into the main components of the brain, by researchers studying mice in California. The experiment, reported in Proceedings of the National Academy of Sciences, skipped the middle "stem cell" stage in the process. The researchers said they were "thrilled" at the potential medical uses. Far more tests are needed before the technique could be used on human skin. Stem cells, which can become any other specialist type of cell from brain to bone, are thought to have huge promise in a range of treatments. Many trials are taking place, such as in stroke patients or specific forms of blindness.
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Study: Robots more expensive, not more effective for surgeryAlthough surgical robots are a must-have for many hospitals and health systems looking to keep pace with their competitors, such technology isn't necessarily any more effective than regular surgery, according to a new study published this week in the Journal of Clinical Oncology. In a study of nearly 2,500 women treated for endometrial cancer, no significant differences were found in the complication rates for women who underwent robotic hysterectomies (1,437) versus women who underwent laparoscopic hysterectomies (1,027). Specifically, 9.8 percent of patients who underwent the procedure without robotic assistance experienced complications--such as bladder injuries or wound infections, according to a Reuters article--while 8.1 percent of patients whose surgeon used a robot experienced such complications.
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Gates Foundation, big pharma, governments partner to eradicate diseasesNeglected tropical diseases - from sleeping sickness to river blindness - got unaccustomed attention Monday when the Bill and Melinda Gates Foundation and a global group of drug firms and government agencies announced a new partnership to knock out 17 diseases that harm 1.4 billion people in developing countries.
The hope is to eliminate five neglected diseases and control five more by 2020, and then figure out the other seven, all from the list of neglected diseases kept by the World Health Organization, a partner in Monday's announcement. more... |
20-1-12
19-1-12
Center for Health Value Innovation Names 2011 FellowsThe nonprofit Center for Health Value Innovation (CHVI) announced its 2011 Fellows, a group of the nation's leading health care executives committed to improving engagement and accountability in health management through value-based designs.
"Faced with mounting costs and declining health status, many organizations have elected to create change through local action," said Jack Mahoney, MD, MPH, CHVI co-founder and chief medical officer. "Engaging all stakeholders in this process is a key component of CHVI's efforts; therefore we are clearly focused on identifying and fostering the success of the individuals who drive this innovation through the Fellows program. We are proud to recognize these leaders who are making substantive contributions in improving the health of their populations and providing the ability for others to follow in their steps." |
17-1-12
Drugmaker earnings to focus on big patent lossesTAKING THE PULSE: The drug industry's patent cliff will likely be in focus when U.S. pharmaceutical companies release their fourth-quarter results. Most recently Pfizer Inc.'s /quotes/zigman/238207/quotes/nls/pfe PFE -0.32% blockbuster anticholesterol pill Lipitor lost U.S. market exclusivity in late November. Besides taking share from Pfizer, generic entries could affect rivals' cholesterol-fighting offerings. In October, Eli Lilly & Co.'s /quotes/zigman/232185/quotes/nls/lly LLY +0.31% top-selling antipsychotic drug Zyprexa lost patent exclusivity. Drug makers have been aiming to expand uses of their older drugs, while increasing their pipelines through collaborations and deals -- in addition to continuing efforts to reduce costs.
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16-1-12
Scientists grow blood vessels using stem cellsScientists have used human stem cells to grow smooth muscle cells (found in blood vessels) that could potentially be used as new treatments for heart and artery problems, according to a study published in the journal Nature Biotechnology.
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10-1-12
9-1-12
First mobile medical app to get CE Mark in UKWhile AirStrip just announced that it had secured a CE Mark for its suite of mobile medical applications last week, it may have not been the very first medical app to secure a CE Mark and be publicly available in the UK market. Another app, created in cooperation with a team of UK-based plastic surgeons, apparently carries that distinction.
The app is called Mersey Burns and it’s currently available for all iOS devices. The Mersey Plastic Surgery Unit helped to develop the app, which aims to help doctors more easily calculate the percentage of a patient’s body surface area that is burned and, in turn, to better calculate the amount of fluid to be administered in the 24-hour period that follows the burn injury. A small study found that those using the app had less variance among estimates for total body surface area that was affected by the burn, while those using paper based assessment tools had greater variance. |
As 'Next Tier Patients' Undergo Gastric Banding and Bypass, GI Device Market GrowsOnce an experimental procedure for severely obese people, gastric bypass, and particularly banding, have become more common, driving gastrointestinal device sales, according to healthcare market research publisher Kalorama Information. The number of procedures for gastric banding has increased 22 times since the early 90's according to Kalorama, and this trend is driving the gastrointestinal device market to $14.6 billion in sales.
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6-1-12
4-1-12
Alnylam, Medtronic RNAi drug-device combo wows with preclinical dataFor years now, scientists have touted the enormous promise of using RNAi treatments to turn off bad genes that cause disease, but delivering the drugs effectively to their target cells, particularly in the brain, remains a challenge.
Alnylam Pharmaceuticals ($ALNY), Medtronic ($MDT) and the nonprofit CHDI Foundation say they've found a way in preclinical trials to effectively deliver their RNAi drug-device combination to treat Huntington's disease to its target in the brain. |
3-1-12
Eight technologies for a healthier 2012Welcome to 2012 and a new list of New Year’s resolutions — a list that likely includes some variation on adopting a healthier lifestyle. Thanks to the acceleration of technology, fulfilling your resolutions this time around may be easier than it was in 2011.
The combination of diet, exercise and sleep, according to my Singularity University colleague Daniel Kraft, are keys to good health. Kraft, a physician-scientist who chairs the medicine track and runs the FutureMed program at Singularity, believes that we can end the obesity epidemic and reduce the incidence of “non-communicable” diseases (such as heart disease) through technology. Kraft helped me put together an assessment of the technologies available today that can help you fulfill your New Year’s resolutions for good health. |
1-1-12
Medtronic pines for medical device innovation in IsraelFinding and maintaining an edge in medical device innovation is the holy grail of companies like Medtronic (NYSE:MDT). In late November, Medtronic CEO Omar Ishrak had this tantalizing tweet about that topic:
Returned from exciting trip to#Israel. Amazing entrepreneurial spirit and energy. Could be next innovation incubator for#Medtronic. Steve Cragle, the medical device company’s spokesman clarified that what Ishrak was tipping his hat to is that Israel is “is one of the most innovative device clusters in the world.” And that innovation is most apparent in the areas of “imaging, software, guidance and electronics,” Cragle said. |
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23-12-11
New Sensor to Detect Lung Cancer from Exhaled Breath Tecnalia, through the Interreg project Medisen, is contributing to develop biosensors capable of detecting the presence of tumour markers of lung cancer in exhaled breath. This is possible because of the changes produced within the organism of an ill person, changes reflected in the exhaled breath of the patient and which enable determining the presence of this type of marker during the initial stages of the disease.
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22-12-11
FDA Proposes Draft Guidelines to improve the representation of women in medical device clinical studiesDraft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," says Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices." |
21-12-11
אקזיט בתחום הביומד: פיינטק נרכשה תמורת 27.5 מיליון דולרבסופו של דבר תחום הביומד הצליח לסגור את השנה עם אקזיט: חברת אופקו בשליטת פיליפ פרוסט, העוסקת בדרך כלל בתחום התרופות לעיניים, הודיעה על רכישת חברת פיינטק הישראלית ב-27.5 מיליון דולר במזומן ובמניות אופקו, הנסחרת בבורסה של ניו יורק ב-1.4 מיליארד דולר.
פיינטק, שיושבת בנשר, היא חברה רווחית העוסקת בייצור של חומרי גלם לתעשיה הרפואית. מוצריה אינם תרופות חדשניות, אלא חומרי גלם המיוצרים בדרך כלל לפי התוויות של חברות אחרות, אך לחברה יש פטנטים לחלק מתהליכי הייצור של החומרים, וכן עובדים עם ידע ייחודי בתחום. חלק ממוצריה אינם ניתנים היום לייצור במפעלים אחרים |
20-12-11
Smartphone detects danger in a heartbeatThe autonomous tool -- developed jointly by the Embedded Systems and Telecommunications Circuits labs at Ecole Polytechnique Federale de Lausanne (EPFL) -- not only automatically identifies anomalies in heart-rate, but also alerts doctors in seconds helping them treat patients more quickly
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19-12-11
17-12-11
New System May One Day Steer Microrobots Through Blood Vessels for Disease Treatment |
Grants to fund device for remote health diagnosisTwo of the biggest spenders on global health innovation are hoping that $38.5 million will be enough money to create a handheld device that doctors could use to diagnose patients far from medical labs.
The battery-powered devices could be taken into remote areas to take samples from patients and provide analysis on various illnesses. For example, if a child has a fever, medical field workers can now test to see if she has malaria. But they can't test to see if she has some other illness, and they wouldn't be able to say exactly which strain of malaria is in her blood. Medical researchers already have developed some of the tests they want to include in the all-in-one device, but pulling them together will be the biggest challenge, said Dr. Peter Singer, chief executive officer of Grand Challenges Canada. |
15-12-11
Medical Device Patient Safety Act Introduced in the Senate; Bill Would Allow for Recall Tracking and Conditional ClearancesOn Thursday, December 15, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the “Medical Device Patient Safety Act.” This bill contains two distinct proposals: (1) to give FDA the authority to track and trend device recalls, and (2) to allow FDA to grant conditional clearances for devices that will be subject to post-market requirements. A summary of the bill is available here.
Recall Tracking. While FDA currently has the authority to track and trend recalls, using information submitted to it under section 519 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and 21 C.F.R. Part 806, it is not required to do so. This bill would require FDA to routinely assess (1) any information provided to FDA in response to a recall request from FDA under section 518(e) of FDCA, and (2) information required to be reported to FDA under section 519 of the FDCA regarding a correction or removal. |
14-12-11
13-12-11
Medtronic Agrees to $23.5M Kickback SettlementMedtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients, the U.S. Justice Department said in a statement.
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Baxter enters agreement to buy Synovis for $325M
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9-12-11
Good Luck With The New Health Care Venture, Microsoft And GEMicrosoft and General Electricannounced yesterday they are forming a joint venture that is essentially centered around a niche Microsoft product called Amalga. Amalga is actually really neat software that pulls a patient’s data from disparate databases and aggregates it, thus giving a clinician the big picture. It will be interoperable, meaning it can communicate with software from different vendors, and Microsoft will work with third party developers to build clinical applications. “The average hospital has 100 different IT systems,” says Nate McLemore, general manager of Microsoft Health Solutions Group. Microsoft has 50 customers using Amalga in 250 hospitals. The two partners say the new company, still unnamed, will be in business next April.
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8-12-11
7-12-11
InfraReDx rounds up a $10M loan deal with GEInfraReDx has developed the TVC Imaging System, an intravascular imaging system based on ultrasound and near-infrared spectrum that can identify plaque within the interior of a blood vessel. The restriction of blood flow because of plaque is believed to cause “the majority of heart attacks,” InfraReDx said in a release, and can complicate the insertion of a stent into a blood vessel.
The TVC Imaging System won approval from the U.S. Food and Drug Administration in September 2010, back when it was known as the LipiScan IVUS Coronary Imaging System. The company followed that up with CE mark approval in Europe to start marketing the system in April. |
4-12-11
1-12-11
3-D Printer Makes Bone-Like MaterialIt looks like bone. It feels like bone. For the most part, it acts like bone. And it came off an inkjet printer.
Washington State University researchers have used a 3D printer to create a bone-like material and structure that can be used in orthopedic procedures, dental work, and to deliver medicine for treating osteoporosis. Paired with actual bone, it acts as a scaffold for new bone to grow on and ultimately dissolves with no apparent ill effects. |
FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvalsThe U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial. “The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”
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30-11-11
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22-11-11
Medtronic Gets FDA Approval For Continuous Glucose Monitoring SystemMedical device maker Medtronic, Inc. (MDT: News ), Tuesday said the U.S. FDA has approved its iPro2, a next generation professional continuous glucose monitoring system that detects glucose excursions which go unnoticed with traditional A1C tests and standard glucose meter measurements. Medtronic believes the iPro2 provides healthcare providers insight into how diet, medication, and daily activities impact patients' glucose levels.
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20-11-11
18-11-11
16-11-11
Given Imaging starts pivotal trial for PillCam COLON 2 in Japan
Israel's Given Imaging ($GIVN) has begun the pivotal PillCam COLON 2 study to support its planned regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency.
The study will evaluate 72 patients between the ages of 40 and 75 with polyps that previously have been identified by optical colonoscopy with the PillCam COLON 2 capsule endoscopy procedure. The primary endpoint of the study is identifying polyps greater than or equal to 6 millimeters. Given expects enrollment will wrap up by the end of March 2012, and a regulatory submission will be ready in the middle of next year. |
11-11-11
שבוע היזמות העולמיכל שנה בשבוע השלישי של נובמבר ייטלו מיליוני אנשים ברחבי העולם חלק בתנועה גלובלית רחבה, מתוך שאיפה משותפת לעידוד היזמות. במסגרת שבוע זה יתקיימו אלפי מפגשים, סדנאות ופעילויות מגוונות בלמעלה מ-115 מדינות ברחבי העולם, למעלה מ-40,000 אירועים, יותר מ-10 מיליון משתתפים, שמטרתם עידוד היזמות האישית, החברתית והעסקית
גם פורום המד טק חוגג את שבוע היזמות העולמי ומארח מפגש בנושא: יזמות, מיתוסים ומציאות בהנחיית דר' אייל בניימין |
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