Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug ...

Some facilities need to register with the FDA to be able to manufacture or sell medical devices, but that doesn’t imply that everything they make is FDA-approved, cleared, or anything else.

Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US. Apple Watch gets FDA-cleared EKG features +6 More ...

The initial sales of the next-generation Swoop® system-purchased by two top-tier hospitals in the northeastern United States-demonstrate a strong market response following FDA clearance and mark a ...