Regulatory FDA launches TAP Pilot to speed access to safe and innovative medical devices The FDA has launched the TAP Pilot Program (Total Product Life Cycle Advisory Program) for manufacturers [...]
Regulatory FDA finalizes guidance on how clinical decision support software is regulated FDA has published final guidance on determining whether clinical decision support software is considered a [...]
Regulatory FDA creates new category of OTC hearing aids, issues PSAP guidance FDA finalized a much-anticipated rule that allows certain air conduction hearing aids to be available [...]
The Upper Valley is home to a growing number of MedTech companies that are changing how we detect, monitor and treat a variety of diseases. Simbex was excited to join the Magnuson Center for [...]
Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions On April 8, 2022, the US Food and Drug Administration published a new draft [...]
