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 sedate uptake of pulsed field ablation (PFA) in Europe failed to presage the enthusiasm that drove the technology’s extraordinarily rapid adoption in the U.S. in 2024. Used to treat atrial fibrillation, PFA received its first U.S. FDA approval in Dec. 2023. At the time, Clarivate estimated that PFA had 7% of the global cardiac ablation market. By year-end 2024, it had 20% and Boston Scientific Corp. projected that PFA would represent up to half of the market by the close of 2025.

As 2025 makes its debut, one of the topics gaining momentum in health care is the diagnosis and potential treatment of neurodegenerative diseases, a scourge that threatens to overwhelm society and drain treatment budgets around the world. One company looking to find solutions to the oncoming neurodegenerative disease tsunami is privately held Sunbird Bio Inc., which is developing blood-based diagnostic platform for neurological diseases like Alzheimer’s and Parkinson’s disease.

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(ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance.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The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of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

Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy.

Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.

China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.