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.
7. FDA panel splits on Abbott’s MitraClip heart implant
The FDA’s Circulatory System Devices Panel was divided this week on recommending approval for Abbott Vascular’s first-of-a kind MitraClip heart implant for the reduction of mitral valve regurgitation.
6. Funding: Topera Medical raises $25 million
San Diego, Calif.-based start-up Topera Medical closes a $25 million funding round for its RhythmView 3D mapping system for arrhythmia.
5. FDA blames poor training for new deaths, injuries tied to Stryker’s recalled Neptune systems
In the months since Stryker’s September 2012 recall of its Neptune surgical waste management systems, the FDA noted additional deaths and injury reports in clinics that opted to continue using the device.
4. Analysts defend Intuitive Surgical as docs defend robot-assisted surgery
Analysts continue to defend Intuitive Surgical amid a Wall Street nosedive as minimally invasive surgeons react in defense of robot-assisted surgery.
3. FDA warns NUVA on Affix implant marketing
NuVasive explains that an FDA warning letter following an inspection at a California manufacturing facility reflects only an issue with marketing – not with any quality systems.
2. Judge bars ex-Stryker marketing director from AAOS
A federal judge bars Blue Belt Technologies’ new hire, ex-Stryker marketing director James Bruty, from attending the annual American Academy of Orthopedic Surgeons conference in Chicago this week.
1. Senate votes 79-20 in favor of medical device tax repeal amendment
The Senate votes overwhelmingly in favor of a non-binding amendment that would repeal the medical device tax and establish a reserve fund to help pay for it.