Medical device giant Edwards Lifesciences wins expanded FDA approval to market its Sapien transcatheter aortic valve replacement systems to lower-risk patients, but the nod comes later than expected and depresses the company's full-year outlook. Edwards Lifesciences (NYSE:EW) won FDA approval to market its Sapien transcatheter aortic valve implantation system to lower-risk patients, despite concerns about limited patient data on the long-term side effects of the device. News Well, 2012, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Pre-Market Approval (PMA), Q3, Replacement Heart Valves, Wall Street Beatread more
Catheter balloons are an important device for a variety of cardiovascular treatments. However, their manufacture can be a complicated process that, if completed wrong, can lead to waste and excess costs. This article highlights a number of innovative technologies that are being offered to help balloon manufacturers ensure their products are defect-free the first time.
Medical device giant Edwards Lifesciences wins expanded FDA approval to market its Sapien transcatheter aortic valve replacement systems to lower-risk patients. Edwards Lifesciences (NYSE:EW) won FDA approval to market its Sapien transcatheter aortic valve implantation to lower-risk patients, despite concerns about limited patient data on the long-term side effects of the device. Food & Drug Administration (FDA), Pre-Market Approval (PMA), Replacement Heart Valvesread more
Israel device maker Syneron Medical gets an FDA nod for its "me" system, the 1st home-use hair removal product cleared for all skin tones. Global aesthetic device manufacturer Syneron Medical (NSDQ:ELOS) landed FDA clearance to market its home-use hair removal system, named "me", directly to consumers. The "me" system, featuring Syneron's proprietary elos energy technology, is the 1st and only FDA-cleared consumer hair removal technology indicated for all skin tones, according to the company. News Well, 510(k), Cosmetic / Aesthetic, Food & Drug Administration (FDA), Regulatory/Complianceread more
Endologix agrees to pay $5 million to settle a patent infringement lawsuit filed against it by Cook Medical over stent grafts for abdominal aortic aneurysms. Endologix (NSDQ:ELGX) agreed to pay Cook Medical $5 million to settle a patent infringement lawsuit over stent graft technology. Legal News, News Well, Patent Infringement, Stent Graftsread more
New material offerings are critical to medical device manufacturers as they provide new opportunities in the development of cutting edge technologies. This three-part round-up features three new materials that are impacting medical device manufacturing in the areas of adhesives/coatings, molding, and extrusion. This part focuses on extrusion.
Today, U.S. Sen. Tom Carper and U.S. Rep. John Carney (both D-Del) announced $4.6 million in funding from the National Cancer Institute at the National Institutes of Health for the Community Clinical Oncology Program (CCOP). CCOP is a network for testing and validating medical interventions against cancer, and for delivering the benefits of scientific discovery to the public and community physicians.
Respiratory devices maker Ventlab recalls more than 14,600 units of its manual respirators after finding that they deliver little to no air/oxygen to patients. Respiratory devices company Ventlab Corp. announced a nationwide recall of thousands of its manual resuscitators over concerns that the devices may not delivery enough or any air or oxygen to patients The recall, which the company initially launched in July, affects more than 14,600 units across 12 different products, including the company's RescueMed Infant Resuscitator and Premium Small Child Resuscitator, according to a press release. News Well, Recalls, Respiratoryread more
Boston Scientific CMO Dr. Keith Dawkins says the medical device company is working on a renal denervation system to treat hypertension. Boston Scientific (NYSE:BSX) is running an internal program to develop a renal denervation device, Dr. Keith Dawkins told MassDevice.com this week. Heading into next week's Transcatheter Cardiovascular Therapies 2012 conference in Miami, the Natick, Mass.-based medical device company's global chief medical officer told us that BSX is planning to highlight several technologies at the show. News Well, Cardiovascularread more
The next evolution is the focus on the supply chain and ensuring the detailed processes are in place and that products/processes provided by downstream suppliers are validated and real. With globalization as the post facto now, it will require more stringent supplier controls from the initial selection of suppliers through the monitoring phases. How will suppliers select and monitor their supplier base?
Carefully applying electricity to the brain can reduce tremors and involuntary movements associated with Parkinson’s disease and a wide range of other conditions, and now a new compilation of major research findings and clinical recommendations is available to help guide referring physicians and other clinicians whose patients might benefit from the therapy.
Boston Scientific could stand to reap substantial rewards by thinking the unthinkable: Follow Johnson & Johnson's Cordis Corp. out of the coronary stents business. Fifteen months ago, Cordis Corp. shocked the medical device world by pulling out of the coronary stent game, a business it helped pioneer. I wonder if its possible Boston Scientific (NYSE:BSX) could someday follow their lead. News Well, Stent Wars, Stents, Wall Street Beatread more
AirStrip Technologies files a lawsuit against mVisum over recently issued patents for remote patient monitoring with an iPhones, iPads and other mobile devices. Mobile health company AirStrip Technologies filed a lawsuit this week against mVisum over recently issued patents for remote patient data monitoring on iPhones, iPads and other smartphones. AirStrip in late August won the patents in question, which detail the process of "mobilizing" physiologic data for smartphones, tablets and other mobile devices. Rival mVisum also develops mobile solutions for receiving, viewing and responding to patient data, including EKGs, alarms and MRIs, among others. Legal News, News Well, mHealth, Remote Patient Monitoringread more
As external industry influences like excise taxes, longer approval process time, and reimbursement pressures bear down on device manufacturers, development partners must look to areas of opportunity and how to best support medical firms in these pursuits. While opportunities such as the growing and aging population and emerging markets are getting a lot of play, it’s also important to realize that progress (i.e., technological advances) poses perhaps the most significant area of opportunity in transforming healthcare.
Quest Diagnostics Announces First EHRs Certified Under Laboratory-based Health IT Quality SolutionsT ProgramOctober 19, 2012 11:00 am | by The Associated Press | News | Comments
Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced the first electronic health record (EHR) solutions to be certified under its Health IT Quality SolutionsT Program. The program is designed to recognize EHR solutions for...