Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.

The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.

The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.

The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.

The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.

Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.

According to a new listing at the FDA device recalls and alerts webpage, Dublin-based Medtronic plc., requested customers quarantine any Bravo CF capsules, an esophageal pH monitoring system.

Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.

The Department of Health and Human Services and private payers have promised to streamline the controversial prior authorization processes in a bid to reduce the attendant controversies.

Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.