The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a strong element of retroactivity to the QMSR.

Oversonic Robotics Srl believes that its humanoid robot Robee could transform health care in Europe as it helps address the challenges of an aging population, rising chronic conditions and the shortage of health care workers. Robee has already received CE mark certification as a class I medical device, and plans are underway to achieve class II certification next year as the company looks to make a significant social impact with its humanoid robot.

The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.

Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon angioplasty matched intravascular lithotripsy in coronary artery preparation of calcification for stent placement.

The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.