Synergy Spine Solutions®, a medical device company focused on improving the quality of life for patients undergoing spine surgery, today announced it has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the Synergy Disc® for 1-level indications at C3-C7.
OXFORD, England, Feb. 26, 2026 /PRNewswire/ — Optellum, the leading AI-enabled solution for earlier lung cancer detection, is thrilled to announce that it has received Therapeutic Goods Administration (TGA) class IIb approval in Australia for the Virtual Nodule Clinic (VNC) platform to support early lung cancer diagnosis.
TORTOLA, British Virgin Islands, Feb. 25, 2026 /PRNewswire/ — Cara Medical Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CARA System, a computed tomography angiography (CTA)-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.
PARSIPPANY, N.J., Feb. 25, 2026 /PRNewswire/ — Scopio Labs today announced it has achieved IVDR certification from BSI, a major regulatory milestone that clears the path for its AI-driven digital morphology platforms in the European Union
ZURICH, Feb. 25, 2026 /PRNewswire/ — Polaroid Therapeutics (PTx) today announces that POLTX_Fiber™ has received the CE Mark as a Class IIb medical device with APT™ (Antimicrobial Polymer Technology).
DALLAS, Feb. 25, 2026 /PRNewswire/ — 4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary TRUSS Implant Technology™, announced that it has received 510(k) clearance to market its SI Joint Truss System™.
SALT LAKE CITY, Feb. 24, 2026 /PRNewswire/ — Xenocor, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the new Xenocor Saberscope®, a single-use 5mm articulating laparoscope designed for high definition (HD) visualization during minimally invasive abdominal (belly) and thoracic (chest) surgical procedures.
NEW YORK, Feb. 24, 2026 /PRNewswire/ — AEYE Health, the leader in ophthalmic AI and retinal diagnostics and the developer of AEYE-DS, the fastest growing solution for diabetic eye exams in the U.S., today announced the publication of a landmark study in BMJ Innovations.
BOSTON, Feb. 23, 2026 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the NexSys PCS® Plasma Collection System with Persona® PLUS technology. Persona PLUS represents the next generation of Haemonetics’ proprietary and patented Persona technology that tailors plasma collections to each donor for improved average plasma volume per donation.
ATLANTA, Feb. 23, 2026 /PRNewswire/ — MiRus® today announced FDA 510(k) clearance and commercial launch of the IO™ Expandable Wedge Osteotomy System, an innovative solution designed to bring intraoperative precision and adjustability to foot and ankle osteotomy procedures.