The U.S. FDA’s attempts to harmonize with other nations on quality management received a dose of good news recently when the International Organization for Standards decided to stand pat on ISO 13485, which also leaves the FDA’s Quality Management System Regulation intact.

The U.S. CMS has confirmed that it will cover renal denervation as a treatment for hypertension in a final coverage memo that largely mirrors the July 2025 draft. One key difference, however, is that Medicare beneficiaries are eligible for RDN after only six weeks of optimized medical therapy, half the three-month waiting period described in the draft.

Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being.

The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a strong element of retroactivity to the QMSR.

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.