The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott Laboratories finally brought the story full circle with a successful national coverage determination that gives the device nationwide coverage for Medicare patients without the need to wrangle with Medicare administrative contractors.

Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The U.S. FDA recently provided a glossary of terms under the heading of recall – a move that comes short of industry’s preference that the term be jettisoned altogether.

The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of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(ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance.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The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of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.