The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory harmonization is that the IMDRF draft overlaps awkwardly with the FDA’s approach, which has issued separate policies for the AI subset of device software functions and a separate guidance for all other devices, including non-AI software.

Roche Holdings AG received CE-mark for the Kidney Klinrisk algorithm, an AI-based tool developed in collaboration with Klinrisk Inc. to stratify risk and assess the progressive decline in kidney function. The software will help clinicians to make more informed decisions when accessing adults with chronic kidney disease as well as individuals with diabetes or hypertension who are at elevated risk of kidney function decline.

Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.

Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.

Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

While the final word has yet to be written, Stryker Corp. came out the biggest winner in a dispute involving four related patents owned by Osteomed LLC, part of Colson Associates’ Acumed.

The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what was borrowed from FY 2025 may make some blue.

The U.K. Medicines and Healthcare Products Regulatory Agency has decided to lean into personalized medicine with the adoption of the concept of a “preference zone” for determining when a therapy can and cannot be used for a specific patient, a concept that is liable to lead to more demanding postmarket surveillance.

AI seems to suggest that a world of problems with health care spending may become more manageable, but Stephen Bittinger, a shareholder in the D.C. office of the law firm of Polsinelli PC told BioWorld that all the headaches surrounding validation of these algorithms suggests a need for an independent AI validation institute.

The market for colorectal cancer screening tests seems poised to heat up considerably with a recent request for Medicare coverage for Genoscopy’s Colosense test, but some who commented on the proposal have misgivings about the lower level of specificity seen in the Colosense relative to the Cologuard.