The U.S. FDA has cleared Artrya Ltd.’s 510(k) for its Salix coronary plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.

The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.

On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.

Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.

Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.

No matter what level of tariff the Trump administration ends up imposing on biopharmaceuticals across the world, drugs and their precursors originating in the EU will face no more than a 15% tariff when imported to the U.S., according to an Aug. 21 EU-U.S. joint statement regarding the trade framework agreement between the two trade partners.

The U.S. FDA released another series of regulations for de novo devices, but the attendant regulation is not always available for these de novo devices.

Australia’s Therapeutic Goods Administration recently reported that it has concerns about the use of digital scribes, stating that any such software that analyzes or interprets clinical conversations may qualify as a regulated medical product.

Neuroone Medical Technologies Corp. expanded into treatment of chronic pain with a new U.S. FDA clearance for use of its Onerf system to treat trigeminal nerve pain. The system uses radiofrequency ablation to disrupt pain signals from the nerve to the brain.

AI and machine learning products have proven complicated for regulatory authorities across the globe, but entities in the business of conducting health technology assessments also have their hands full according to several sources.