Highlife SAS secured CE mark for its transcatheter mitral valve replacement (TMVR) system, bringing a much needed treatment option for patients with limited alternatives. The Highlife TMVR system is indicated for individuals with symptomatic moderate-severe or severe mitral valve regurgitation who are unsuitable for surgical repair or replacement and transcatheter edge-to-edge repair.

The U.S. Department of Justice reported that it has indicted two executives with Zynex Inc. for Medicare fraud, but in one of the stranger twists in recent fraud cases, one of the executives allegedly attempted to interfere with the personal lives of members of the media who were reporting on the company’s legal problems.

Cryoablation for Barrett’s esophagus is something of a novelty, and the U.K. National Institute of Health and Care Excellence is considering an endorsement of the treatment.

The FDA’s Center for Devices and Radiological Health posted two important guidances just in the first week of the new year. The agency seems determined to sustain that pace with a new draft guidance for cuffless blood pressure monitors, apparently in response to sales of unauthorized over-the-counter devices for this indication.

The European Commission recently published the results of a study of the impact of the EU regulatory environment, which confirmed the worst fears of some observers about the situation in the EU. The report said that the associated challenges are prompting small and medium companies to pull at least one product out of inventory for the EU market, with some companies abandoning the EU altogether.

Boston Scientific Corp.’s intent to acquire Penumbra Inc. for $14.5 billion will not only allow it to expand its minimal invasive care portfolio in areas such as embolization and peripheral vascular disease, but to also reenter the neurovascular space, Kathleen Van Vlierberghe, vice president of Peripheral Interventions EMEA, told BioWorld.

Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.

The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.

The U.K.’s National Institute for Health and Care Excellence is revisiting its policy for osteoporosis and may recommend that clinicians include vertebral fracture assessment with dual energy X-ray absorptiometry procedures.

Abbott Laboratories received CE mark in Europe for the Tactiflex Duo ablation catheter to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device, were completed in the EU this week.