The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time. Read More
LONDON – Kaia Health Software GmbH closed an $8 million funding round that it will use to accelerate U.S. commercialization of its digital health apps for managing musculoskeletal disorders and chronic obstructive pulmonary disease (COPD). Read More
Washington-based life sciences conglomerate Danaher Corp. has executed a long-anticipated spinout for its dental products business Envista Holdings Corp. via a $589 million IPO. Based in Brea, Calif., the company priced a bit below the middle of the anticipated share price range at $22 and sold 26.8 million shares, as it had planned. Read More
