The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.

The question of how to define artificial intelligence (AI) for medical product usage was answered by the FDA, which recently offered an AI glossary.

GE Healthcare Technologies Inc. received U.S. FDA approval for its novel radiotracer, Flyrcado (flurpiridaz F-18), for use in the diagnosis of myocardial ischemia or infarction in patients with known or suspected coronary artery disease.

The U.S. FDA has guidances on the books for dental products, but the it unleashed a quartet of guidances – ceramics and cements used in dental procedure – for dental products on the final Friday of September 2024. The agency also issued a guidance without comment – unusual for the FDA – for the well-known, terror-striking pneumatic dental hand tool.

Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20.

Both chambers of the U.S. Congress put aside their election year politicking Sept. 25 long enough to pass a continuing resolution that will keep the government running at its current funding level through Dec. 20. The spending bill is now awaiting President Joe Biden’s signature.

The U.S. FDA’s inspection of two facilities run by San Francisco-based Irhythm Technologies Inc., illuminated some of the usual problems with corrective and preventive action. The agency indicated that problems with skin irritation associated with the company’s Zio device should have been handled as medical device reports, a view the company apparently did not share.

The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.

Michelle Tarver, the acting director of the U.S. FDA’s device center appeared on a Sept. 24 webinar to discuss her priorities for the agency going forward, one of which is global health equity.

The U.S. FDA wrapped up the pilot version of the Accreditation Scheme for Conformity Assessment (ASCA) and reported the formation of a permanent ASCA program, which has been seven years in the making.