The FDA may be freed up to put its user fees to use for product review for medical devices and drugs, if a bipartisan bill introduced in the House passes. In essence, the bill exempts the FDA user fees from sequestration and may take one burden off the already slow approval process. That adds up […]
As part of its effort to be more transparent and loop patients into its processes and policies, the U.S. Food and Drug Administration this week launched a new website called FDA Patient Network. It’s meant to be an educational resource for patients, patient advocates and consumers to learn about drug and device approval, off-label use […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Irvine-based Agendia complains that while it spent huge amounts of time, energy and resources to gain formal approval from U.S. Food and Drug Administration for its breast-cancer test, its chief rival, Genomic Health Inc., has chosen to bypass federal ...
A week after the Congressional hearings discussed how the US Food and Drug Administration’s impending regulatory guidelines (expected by October) will impact mobile health apps, aspiring and current digital health entrepreneurs may be rethinking their path. In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital […]
If this is the way most House hearings go, I can see why nothing gets done in Washington. On the third day of hearings about FDA regulations of mobile medical apps, there was still lots of fear about uncertainty and the medical device tax. Dr. Farzad Mostashari and Christy Foreman of the FDA testified in […]
(Reuters) - A slim majority of advisers to the U.S. Food and Drug Administration voted on Wednesday for approval of Abbott Laboratories' implantable heart device MitraClip, saying it had more benefits than risks. The eight members of the advisory panel...
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
It’s easy to get excited when really intriguing and previously unthinkable technology reaches the marketplace. For example, there’s been a lot of hype in the news leading up to the U.S. Food and Drug Administration’s announcement today that it approved Second Sight Medical’s Argus II Retinal Prosthesis system — the world’s first bionic eye. The […]
Minnesota orthopaedics device startup Conventus Orthopaedics announced Monday that the U.S. Food and Drug Administration has approved its minimally invasive treatment for repairing wrist fractures. The Conventus Distal Radius Surgical System is a self-expanding implant that requires small incisions and is able to reduce “surgical trauma by as much as 80 percent compared to traditional […]
Medical device maker Dune Medical Devices announced Wednesday that the company has received a pre-market approval from the Food and Drug Administration for its breast cancer detection device. The MarginProbe System can be used following the removal of cancerous tissue to know whether there is cancer in the immediate vicinity of the excised tissue. It […]
Now equipped with U.S. Food and Drug Administration clearance to market its first product, University of Michigan spinoff Tangent Medical Technologies has raised $8.6 million, presumably to take its closed-system IV device to market. The financing came from nine investors in an equity offering this month, the company said in a U.S. Securities and Exchange […]
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
For years ophthalmologists have been using the drug mitomycin C off-label to modulate wound healing during eye surgeries. In glaucoma filtering surgery, it’s known to prevent post-operative scarring and reduce the risk of surgical failure. But it’s tricky to work with, and until recently no one had taken on the work of getting it FDA […]
Cook Medical has received FDA approval for the first drug-eluting stent to treat peripheral artery disease in the U.S. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding metal stent coated with the drug paclitaxel to help prevent recurring narrowing of the artery. Drug-eluting stents are currently approved for use in coronary arteries in heart […]
Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female uterine fibroids. The device uses RF ablation to treat just the fibroids and is an alternative to traditional fibroid surgery where “layers of healthy tissue […]
Salt Lake City, Utah-based Amedica announced Thursday that it has received regulatory clearance for the second generation of an interbody fusion device system. The U.S. Food and Drug Administration has cleared its cervical and lumbar interbody fusion devices (IBF) made with a proprietary biomaterial. These devices and their design improvements will help surgeons perform minimally invasive […]
A proposed guidance to expedite the acceptance process for the 510(k) program at the U.S. Food and Drug Administration would require the agency to respond in 15 days to an applicant. In that period, FDA reviewers would look at whether the application is complete from an administrative point of view. The goal is to ensure […]