Mark McCarty

The U.S. Centers for Medicare & Medicaid Services has posted the home health final rule for calendar year 2026 and has established a framework for competitive bidding for products such as continuous glucose monitors, a move that is struggling to find support among stakeholders.

The Office of Inspector General issued a report stating that the Medicare program could save “tens of millions of dollars” in a single year on continuous glucose monitors and associated supplies if the Centers for Medicare & Medicaid Services acted to apply price pressure on suppliers.

The European Commission posted a series of proposed legislative updates, including the AI Act, which might not come into force for the med tech industry until August 2028 under the terms of this proposal.

The U.S. Environmental Protection Agency has moved to relax reporting requirements for perfluoroalkyl and polyfluoroalkyl substances used in a variety of applications, including medical devices.

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.

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.

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.

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The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a strong element of retroactivity to the QMSR.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