Medtronic’s MiniMed Go earns FDA clearance. Learn how it could reshape insulin injection therapy by combining smart pens, CGM insights, and dose algorithms.
Avatar Medical is set to introduce Eonis Vision, a glasses-free 3D medical imaging system, at CES 2026. The product, developed in collaboration with Belgian display specialist Barco and powered by high-performance Dell hardware, is aimed at enhancing the clarity of doctor–patient communication. While the original Avatar Medical Vision software is already FDA-cleared, the updated version […]
RevBio Inc. has received approval from the United States Food and Drug Administration to initiate a pilot clinical trial evaluating TETRANITE, its regenerative bone adhesive, for dental ridge augmentation procedures. The trial will examine whether the product can eliminate the need for membranes, meshes, tacks, and fixation screws—elements that have traditionally been considered essential for […]
Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation […]
FDA clears Deseyne, the first EDOF contact lens for presbyopia. Find out how it could reshape non-surgical vision correction in the U.S. market.
Biobeat raises $50M to commercialize its FDA-cleared patch-worn ABPM system. Find out how this device could change hypertension care in the U.S.
Bendit Technologies has secured 510(k) clearance from the U.S. Food and Drug Administration for its Bendit17 steerable microcatheter, a device the company describes as the smallest steerable microcatheter available for use in neurovascular and peripheral endovascular interventions. With U.S. commercialization slated to begin in January 2026, the Israel-based medical device manufacturer is also pursuing regulatory […]
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study […]
Medtronic’s Hugo robot gets FDA clearance for urology. Explore how it could reshape U.S. robotic surgery and challenge incumbent systems like da Vinci.