The U.K. Medicines and Healthcare products Regulatory Agency is calling for unified standards to harmonize microbiome research, after revealing major inconsistencies in the results when labs around the world analyzed identical reference samples of gut bacteria.

A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer.

The resolution of the budget impasse between Democrats and Republicans on Capitol Hill sidestepped a number of problems, including some cuts to Medicare payment rates for clinical laboratory testing services. However, that pause is only in effect through the end of January 2026, leaving operators of these labs with a fiscal sword of Damocles to manage.

The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.

Aesculap Implant Systems LLC has seen its share of bad news recently, but the company seems to have cleared the legal deck with an agreement to pay $38.5 million per a Nov. 17 announcement by the U.S. attorney’s office for the district of Eastern Pennsylvania.

Over a span of five-and-a-half months this year, 3.5% of the more than 11,000 clinical trials funded by the U.S. NIH had their grants terminated, according to an article published in the Nov. 17 JAMA Internal Medicine. That’s 383 trials that lost funding.

The Medicare Wasteful and Inappropriate Service Reduction (WISeR) proposal is designed to tamp down on waste, fraud and abuse in the Medicare program, but Jeff Wurzberg, a partner at Norton Rose Fulbright LLP, told BioWorld that the contractors developing these AI models have incentives to return non-covered determinations for services.

Exactech Inc., of Gainesville, Fla., decided it will not subject itself to a 10-year corporate integrity agreement with the Office of Inspector General, an understandable move given that the company no longer intends to do business in the U.S. under its old brand.

Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.

The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.