The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.

Beijing’s policy of favoring domestic medical technology is a matter of record, but the European Commission apparently heard enough from EU med tech firms to take action. The Commission posted notice that it may take steps to retaliate by restricting bids from China for EU government contracts in retaliation, a move certain to draw cheers from European device makers.

U.S. Medicare coverage of renal denervation (RDN) for uncontrolled hypertension may soon be a fact of life if the manufacturers of these systems have their way. CMS opened a national coverage analysis for RDN, but as is routine practice recently, the agency is asking for comment before posting even a draft coverage memo for this technology.

The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design.

The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.

The discussion about taxpayer appropriations for CMS has been ongoing for decades, leading to futile speculation regarding user fees for the agency. Louis Jacques, who formerly worked at CMS, told BioWorld that Congress tends to be somewhat reactive when it comes to appropriations for CMS – a dynamic which suggests that appropriations for CMS are not likely to improve significantly in the near term.

The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these questions. The draft guidance recommends that new and existing devices be evaluated to establish performance across different pigmentations, a development that would address concerns among clinicians and patients alike.

Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.

Some people may have seen 2024 as the year of artificial intelligence (AI) in med tech, but the FDA is off to a strong start in 2025 with a dual-purpose AI draft guidance. While the draft covers both premarket submissions and life cycle management considerations, the more important consideration is that the FDA’s centers for devices, drugs and biologics have all signed off on the draft, suggesting an agency-wide convergence in thinking about AI.

Regulatory overhauls are never a simple affair, but the med tech industry ran into an amorphous, ennui-inducing mess in dealing with the EU Medical Device Regulation almost immediately. Even though the underlying legislation passed in 2017, the MDR impasse continued to impede innovation on the continent – a problem that might be only partly resolved in 2025.