Medtronic plc's Sphere-360 secured a CE mark – the second catheter in its Affera PFA franchise – as it announced completion of the first cases in its investigational device exemption HORIZON trial for the Sphere-360 in the U.S. The device is indicated for treatment of paroxysmal atrial fibrillation (AF), an intermittent erratic heartbeat that can progress to persistent AF. Atrial fibrillation affects more than 10.5 million people in the U.S. and 60 million globally. Read More
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. Read More
After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend. Read More
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. Read More
In a lawsuit that’s been bouncing through the courts for years, the U.S. Court of Appeals for the District of Columbia once again cleared the way for several biopharma and medical device companies to potentially be held liable, under the Anti-Terrorism Act, for terrorist attacks against hundreds of Americans in Iraq. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Imagine Devices, Scisparc, Xylo Technologies, Zynex . Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueocean Global, Highlife, Intuitive Surgical, Mannkind. Read More
