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.

In some ways, remote patient monitoring (RPM) came of age during the COVID-19 pandemic, but payers still worry about the potential for fraud and abuse. A recent report from the U.S. Office of Inspector General supported concerns about fraud and abuse with RPM, a problem CMS will have to address to constrain unnecessary and potentially illicit spending.

Korean med-tech firm Innosys Co. Ltd. recently launched two new injectable spine bone graft substitute products – Velofuse Gel and Velofuse Putty – and announced a name change to CG Medtech Co. Ltd., effective Nov. 4, 2024.

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.

The U.S. Court of Appeals for the Federal Circuit remanded a patent case to district court after finding that a patent applicant need not invoke identical terminology when describing a central feature of a catheter technology across multiple patents.