Medtronic plc's Sphere-360 secured CE marking for the second catheter in the Affera PFA franchise as it announced completion of the first cases in its investigational device exemption trial for the Sphere-360 in the U.S. The new catheter enables adjustment to its lattice design, allowing it to conform to the shape of the veins and deliver pulses of energy without needing to rotate the catheter.

Highlife secures CE mark for TMVR system

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.

Zynex officials indicted for health care fraud

The U.S. Department of Justice reported that it has indicted two executives with Zynex Inc. for fraud in connection with the company’s electrodes and other equipment and supplies. Bizarrely, the company’s CEO, Thomas Sandgaard, allegedly attempted to interfere with the personal lives of members of the media who were reporting on the company’s legal problems, including one instance in which Sandgaard purportedly attempted to convince the reporter’s spouse that the reporter was having an extramarital affair.

Drug, device companies could still be liable for terrorist claims

In a lawsuit that’s been creeping through the courts for nearly a decade, 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 hundreds of terrorist attacks against Americans in Iraq. The opinion in Johsua Atchley v. Astrazeneca, handed down Friday, made it clear that while “liability does not attach to those who … passively and tangentially aid terrorists in the ordinary course of their business,” this complaint described conduct that is far from “business as usual.”

NICE wants more evidence for Barrett’s esophagus treatment

Cryoablation for Barrett’s esophagus is something of a novelty, and the U.K. National Institute of Health and Care Excellence (NICE) is considering an endorsement of the treatment. Still, NICE said it wants to see more data before it will lend the therapy its full-throated endorsement, although it is not the only entity that harbors misgivings about the current evidentiary state for this therapy.

Med-tech gainers and losers for Jan. 19-23, 2026

The top 10 med-tech stock gainers and losers for the week.

Also in the news

Blueocean, Highlife, Imagine Devices, Intuitive Surgical, Mannkind, Neotech Products, Prospera, Scisparc, Xylo Technologies, Zynex