The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.
The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.
A committee of the House of Representatives advanced a bill that if passed will give eligible breakthrough medical devices four years of Medicare coverage.
The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.
Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
The Trump administration released an action plan for AI, which includes an exports program for full-stack AI in areas such as health care. The announcement drew the support of the Advanced Medical Technology Association, which described the initiative as an accelerant for the use of AI in health care and a boon to patient outcomes.
President Donald Trump signed House Resolution 1, the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year.
The Trump administration’s tariff activities provoked another set of responses from both Medtech Europe and the Advanced Medical Technology Association.
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
