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. Regulators Down Under issue a hazard alert on J&J’s shoulder surgery guides
The Australian Dept. of Health puts out a health alert for a single lot of J&J Glenosphere Orientation Guides, used during shoulder replacement surgery.
2. FDA approves new safety features in St. Jude’s next-gen high-voltage defibrillators
St. Jude Medical won FDA approval for its portfolio of next-generation high voltage defibrillators featuring new safety features that provide extra electrical insulation and prevent shorts from obstructing life-saving therapy.
1. AdvaMed on the 510(k): Leave well enough alone
Medical device industry lobbying group AdvaMed urges the FDA to avoid making needless changes to the 510(k) medical device review pathway, particularly to the rules for when device modifications merit a new application.
