The U.S. CMS has adopted an aggressive payment policy for skin substitutes in the Medicare physician fee schedule for 2026, although the payment rate is sufficiently higher than the agency had proposed to mollify some critics.
Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon angioplasty matched intravascular lithotripsy in coronary artery preparation of calcification for stent placement.
The Office of Inspector General (OIG) said in a new report that the U.S. Medicare program had overpaid a group of providers of durable medical equipment (DME) by nearly $23 million between 2018 and 2024, an amount that is a significant drop from prior years, but which OIG said calls for further reforms for the Medicare DME program.
The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.
Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
Cordis Corp. has quite a bit to crow about in this latter part of October 2025 with the unveiling of results of two studies that back the Miami Lakes, Fla.-based company’s Selution SLR drug-eluting balloon (DEB) for both de novo coronary artery stenosis and in-stent restenosis.
Doctors and device makers are habituated to the notion that more devices equal better outcomes, but one presenter at this year’s Transcatheter Cardiovascular Therapeutics meeting in San Francisco argued that this is not always the case. James McCabe of Beth Israel Deaconess Medical Center in Boston said cardiologists may want to start thinking about whether a cardiology implant should stay implanted, a mindset that is anything but intuitively attractive to the modern practicing physician.
In San Francisco, the first day of Transcatheter Cardiovascular Therapeutics 2025 annual meeting offered presentations on the future of the convergence of devices, drugs and AI. The takeaway from the session seems to be that while the future is bright, it will become the present only when payers can find an economic argument to pay for the advances formed by this convergence.
India’s Central Drugs Standard Control Organization (CDSCO) posted a draft guidance for medical device software, providing some clarity about the agency’s expectations for this class of products even if it seems to break no new ground.
The Advanced Medical Technology Association has updated its code of ethics for interactions with health care professionals, which includes some much-needed updates that address both the burgeoning reliance on data and the increasing emphasis on the part of U.S. regulators on data security.
