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Nearly two years after the FDA approved hearing aids to be sold OTC without involvement of a licensed professional, a Government Accountability Office (GAO) study found that barriers to treatment remain, and stakeholders believe prices are too high. Read More
Recalled products from Medtronic and Megadyne have been deemed Class I by the FDA — Medtronic for a potential software issue and Megadyne for the potential for burn injuries during surgery. Read More
DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that users can leave their phone behind and still receive timely readings. Read More
Two devicemakers in Mississauga, Ontario — Techlem Medical and Trexo Robotics Holdings — received recently released FDA Warning Letters with Techlem cited for quality issues and Trexo for marketing unapproved products. Read More
Examples of the items the FDA has refused admission include those used to diagnose, prevent, or treat COVID-19 such as test kits, respirators, and face masks. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
OptumHealth Care Solutions has recalled its Nimbus II Plus infusion pumps — a recall now deemed Class I by the FDA — because of the potential for the device to fail from a variety of issues. Read More