Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
7. Focus on safety, not efficacy, says former FDA chief
Former FDA commissioner Andrew von Eschenbach turned heads by calling on the federal watchdog agency to abandon efficacy testing when considering new drug and device applications.
6. Diabetes: Insulet inks deal with J&J’s LifeScan for next-gen OmniPod
The next generation of Insulet’s (NSDQ:PODD) OmniPod insulin pump, which is awaiting 510(k) clearance from the FDA, will be compatible with the LifeScan blood glucose monitoring technology made by Johnson & Johnson (NYSE:JNJ).
5. HeartWare gains after landing a date with the FDA
HeartWare International (NSDQ:HTWR) shares closed up 2.4% after the company won a hearing date before the FDA’s circulatory system devices panel in April.
4. Stryker’s Wingspan brain stent gets a date with the FDA
The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.
3. Stryker, ex- CEO MacMillan still working on exit package
Stryker Corp. (NYSE:SYK) and former CEO Stephen MacMillan are still working on the terms of a separation agreement after his abrupt resignation last week, company officials said yesterday.
2. Consumer groups, medical device makers spar during MDUFMA III hearings
Consumer advocacy groups urged the U.S. House of Representatives to take a stronger hand in promoting safety in medical devices during a hearing on the re-authorization of the medical device user fee act.
1. Paulsen: Med-tech tax repeal vote may come this year
The medical device tax repeal effort should hit the U.S. House floor for a vote this year and has more than enough support to pass, according to bill author Rep. Erik Paulsen (R-Minn.). The measure has gained momentum, with 228 representatives signing on as co-sponsors of the tax repeal bill, Paulsen told MassDevice.
