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This edition of Quick Notes looks at the FDA alerts and letters regarding artificial ankle failures, operating tables moving unexpectedly and unlatched incubator panels. Read More
Medtronic has filed a patent infringement lawsuit against Axonics in two venues and also faces a Class I recall of its Duet system used to drain cerebrospinal fluid. Read More
The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid becoming a burden on manufacturers, according to many of the 28 comments posted. Read More
Soft tissue markers BioZorb and BioZorb LP pose a potential risk of serious complications said the FDA in a safety communication released Tuesday. Read More
While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist. Read More
Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin have not been authorized, cleared or approved by the FDA, the agency has warned in a recent safety communication. Read More