MedTech News

FDA Clearance and First in Human Use for SoloPace™ Temporary Pacing System for TAVR

SAN FRANCISCO, April 17, 2025 /PRNewswire/ — Solo Pace Incorporated, an emerging medical technology company, announced both FDA Clearance and First-In-Human use of their SoloPace Control System for temporary pacing in Transcatheter Aortic Valve Replacement (TAVR) procedures. With standardized workflows, the Control System is engineered to improve TAVR temporary pacing efficiency and reduce patient risks. Initial cases were completed this month at Scripps Clinic by Chief of Cardiology, Paul Teirstein, MD and Curtiss Stinis, MD.

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Sanoculis Receives CE Mark for MINT® Product for the Treatment of Glaucoma

TEL AVIV, Israel, April 17, 2025 /PRNewswire/ — Sanoculis Ltd., a company specializing in ophthalmic medical device technologies, today announced that it has received CE Mark approval under the Medical Device Regulation (MDR) in the European Union (EU) for its MINT® (Minimally Invasive Nasal Trabeculostomy) product—an innovative, stent-free technology platform for the treatment of adult patients undergoing glaucoma angle surgery.

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THINK Surgical Announces First Use of Maxx Orthopedics’ Freedom® Total Knee implant with the TMINI® Miniature Robotic System

FREMONT, Calif., April 16, 2025 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced the successful first use of Maxx Orthopedics’ Freedom Total Knee implant utilizing the TMINI® Miniature Robotic System by Dr. David V. Cashen, a Joint Replacement specialist at Coastal Orthopedics Surgery Center in Bradenton, Florida.

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LUMA Vision Receives FDA Clearance for VERAFEYE 2D/4D Cardiac Visualization Platform

DUBLIN, April 16, 2025 /PRNewswire/ — LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This novel catheter-based imaging system provides real-time, two and four-dimensional, 360-degree visualization, significantly enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters, which in the future, will further empower clinicians to perform complex procedures with greater precision and control.

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