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The FDA’s Medical Imaging Drug Advisory Committee (MIDAC) meets Tuesday to tackle concerns about Lumisight, a device-injection combo product from Lumicell designed to help clinicians detect residual breast cancer following tumor removal. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
When it comes to integrating artificial intelligence into healthcare networks, stakeholder enthusiasm appears to be outstripping FDA oversight, according to a survey by the Berkeley Research Group. Read More
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The FDA’s draft guidance describing how device manufacturers can use real-world evidence (RWE) to support regulatory applications is a good start, but needs some refinement to avoid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