At first glance, the results of the CLOSURE-AF study would seem to spell doom for left atrial appendage closure devices for patients at risk of stroke, but there is some noise in the signal, including that the devices used in the study no longer represent the state of the med-tech art.

Patients and their doctors are no fans of long-term use of direct oral anticoagulants (DOACs) after ablation treatment for atrial fibrillation, but three-year data from the OCEAN trial suggests that some patients may not need these DOACs after all, an outcome that qualifies as a crowd-pleaser for all but the makers of these pharmaceutical agents.

Shares of Mountain View, Calif.-based Heartflow Inc. have oscillated significantly over the past three months, but the results of a study of the company’s plaque staging system have breathed new life into the company’s shares, boosting them by 7% in Nov. 10 trading.

Kestra Medical Inc. seems to have put itself in a position to take a bite out of the market for wearable defibrillators with the results of the ASSURE WCD study, which enrolled more than 21,600 patients. The study, whose results were reported on at the American Heart Association annual meeting in New Orleans, demonstrated that Kestra’s unit delivered an inappropriate shock rate of only 0.0065 per patient per month, an outcome that analysts at Wells Fargo said will allow Kestra to close the gap on competitors such as Zoll Medical.

The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.

The U.S. Patent and Trademark Office (PTO) has resurrected a previous policy that requires parties to a proceeding at the Patent Trial and Appeals Board to disclose all the parties of interest in the proceeding. PTO said this shift is driven in part by national security considerations, but the reversal forces participants in PTAB proceedings to disclose the identity of any affiliates that may have an interest in the outcome lest the petition for an administrative hearing be denied.

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.