The IOM recently releasing a report recommending a complete overhaul of the process used by the government to approve medical devices.
Healthcare
Star Trek technology to speed diagnosis
Leicester University has developed a new ‘Star Trek-style’ medical suite to help diagnose hospital patients with potentially serious diseases.
NICE recommends warming mattress
NICE (National Institute for Health and Clinical Excellence, UK) has published guidance supporting the use of a patient warming mattress from a Yorkshire company to prevent hypothermia during surgery.
FDA may revoke 510(k) clearances for transvaginal mesh products
Recent warnings and pressure from public groups may see transvaginal mesh devices bumped up to a higher risk FDA classification.
FDA May Classify Surgical Mesh Devices as High Risk
Blog from Injury board network discussing 510(k) classification of surgical meshes in context of current high profile medical device-related concerns.
Medtronic Reports Positive Results with CoreValve and Acquisition of Peak Surgical, Salient Surgical Technologies
Investigators reported that cardiac survival of patients, who were implanted with the 21F CoreValve system in 2005 and 2006, was 77.9 percent at two years and 68 percent at four years; in other Medtronic news, company announces completing the acquisition of Peak Surgical Inc. and Salient Surgical Technologies Inc.
Balloon pump use prior to PCI does not reduce infarct size in STEMI patients without shock
Intra-aortic balloon pump counterpulsation prior to PCI in patients with ST segment elevation MI does not reduce infarct size as measured by MRI, according to results from the Counterpulsation Reduces Infarct Size Acute Myocardial Infarction (CRISP AMI) trial.
Researchers create artificial lung that works with air rather than pure oxygen
Researchers have created an artificial lung that uses air as a ventilating gas instead of pure oxygen – as is … continue reading “Researchers create artificial lung that works with air rather than pure oxygen”
CERMA Creates Spin-Off Company CERMAVEIN to Commercialise Steam Vein Sclerosis (SVS(TM)) Technology in Varicose Vein Market
French emerging medical technology company CERMA, specialized in the development of innovative and minimally invasive devices in phlebology and oncology, announced today the creation of spin-off CERMAVEIN
Medical Devices Outperform Market But Rule Changes Loom
Medical devices are the overlooked step-child of the biopharma industry but the latest MassDevice Weekly shows this sector to be … continue reading “Medical Devices Outperform Market But Rule Changes Loom”
Flexible-Fiber CO2 Laser Useful in Transsphenoidal Surgery
A new study demonstrates that flexible-fiber CO2 laser can safely cut and coagulate during endoscopic assisted transsphenoidal craniotomies (TSC), without the line-of-sight problems encountered with conventional CO2 lasers.
Nano Mask signs agreement with Saudi medical products distributor
Nano Mask has entered into an agreement with a Saudi Arabia-based medical products distributor to sell its dual filtration systems.
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
Sheffield healthcare company delivers world’s first biodegradable oesophageal stent
A Yorkshire based company supplying the world’s first biodegradable oesophageal stent attended a global conference in the Czech Republic last month to discuss the revolutionary technology that will reduce costs, prevent discomfort and cut infection.
IOM to FDA: Ditch the 510(k) clearance program for medical devices
The Institute of Medicine’s much-anticipated independent review of the FDA’s 510(k) clearance program for medical devices recommends that the entire program be scrapped in favor of a new protocol to ensure the devices are safe and effective. Medtronic officials and Sen. Scott Brown (R-Mass.) react.
Growth of Chronic Kidney Disease Highlights Need for Early Detection
An increasing numbers of patients progressing to kidney disease and kidney failure place a financial strain on public health systems.