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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
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
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
The FDA has finalized a rule allowing it to destroy illegal medical devices valued under $2,500 that have been refused admission into the US as a deterrence against sellers re-shipping items previously refused admission. Read More
A clinical laboratory trade association and one of its member companies have filed suit against the FDA, asking the agency to overturn its final rule to regulate lab-developed tests (LDT) as medical devices claiming that the FDA doesn’t have the authority to scrutinize LDTs. Read More