The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS tacks three years onto CJR, revises target price calculation; Connect for Health Act back in play; More bezel troubles for Alaris 8100; CMS announces two meetings for FY 2022 lab fee schedule.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arup Laboratories, Conventus-Flower, Cynosure, Evon Medics, Genome Medical, Midiagnostics, Myellevate, Patientsafe Solutions, Red One Medical, Specific Diagnostics, Techcyte, Vocera.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Guardant Health, Haemonetics, Intersect ENT, Medtronic, Paige.Ai, Skylinedx.
New hires and promotions in the med-tech industry, including: Bioventrix, Exponential AI, Iron Bow, Midiagnostics, Real Chemistry, Shape Memory Medical, Signify Health.
Keeping you up to date on recent developments in neurology, including: Detecting brain damage in babies earlier with new infrared scanner; VR treatment for PTSD to be evaluated in clinical trial; NIH study identifies diverse spectrum of neurons that govern movement.
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
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