Apple Watch 4 Gets FDA Clearance
The product can conduct electrocardiograms and measure the heart’s rhythms.
FDA Awards $6 Million in Grants for Pediatric Device Development
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
FDA Issues Draft Guidance on Considerations of Uncertainty in Making Benefit-Risk Determinations for Premarket Decisions
The agency is aiming to provide more transparency and consistency in this area.
“We Are Now Out of Time”: Theranos to Dissolve
The Wall Street Journal reports that the scandal-ridden company will dissolve after failing to sell itself, and investors will lose nearly $1 billion.
Top MedTech Summer Stories
Following protocols and maintaining compliance have been common themes.
Alcon Voluntarily Withdraws CyPass Micro-Stent from Market
The decision was made after analyzing data from a long-term safety study.
Developing a Cardiovascular Pediatric Device? You Could Win $100,000
The Children’s National Health System is accepting proposals for technologies that address unmet needs in children.
FDA’s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
FY 2019 Medical Device User Fees Increase 4%
The increase is significantly less than FY 2018, which saw user fees go up 33%.
Bayer to Stop Selling Essure Permanent Birth Control Device
The device will no longer be available after December 31, 2018.
