Tokyo-based Olympus Corp. launched a new video imaging platform called Visera S (OTV-S500) in Europe and select Asian countries September 2024 while advancing more rollouts for the product worldwide.

The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade.

The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.

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.

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.