Medical device companies' aggregate spend on payment and other gifts to physicians was at least $200 million last year, according to the U.S. Health & Human Services Dept., but critics (and the agency itself) flag widespread problems with the Open Payments database.
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
Abiomed says it's come to an agreement with the FDA on an indication for its flagship Impella 2.5 heart pump, and now expects to win pre-market approval early next year without a hearing before an FDA advisory panel.
Here's a look at some of the top Wall Street stories for medical device companies this week: Medtronic updates on $43B Covidien deal financing; Boston Scientific, Bard CEOs cool on consolidation; Nevro sets range for IPO of up to $106m; Alere to sell Alere Health unit to Optum for $600m; Skyline Medical conducts 1-for-75 reverse stock split
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
By William Maisel, M.D., M.P.H.
For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can't help that patient pick up a glass of water. But devices can – and do.
In recent months, FDA has reviewed a number of noteworthy products for people with disabilities. And it has approved, cleared or allowed manufacturers to market several new devices.