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.
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.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Imagine Devices, Scisparc, Xylo Technologies, Zynex .
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueocean Global, Highlife, Intuitive Surgical, Mannkind.
Researchers have developed an AI-based wearable device, called Revoice, to help individuals communicate effectively after a stroke. The system, worn around the neck, uses sensors to capture carotid pulse signals and subtle vibrations from throat muscles to reconstruct intended words and sentences in real time, potentially transforming the lives of stroke patients living with dysarthria.
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