Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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.
3. FDA inspectors warn NuVasive on marketing for Affix spinal implants
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. 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.
1. FDA recommends against approval for Abbott’s MitraClip implant
The FDA recommends against premarket approval for Abbott’s MitraClip mitral regurgitation treatment, saying the medical device maker needs to provide more data on the safety and effectiveness of the device.
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