Sibel Health’s ANNE One platform secures EU MDR CE mark
June 11, 2026
ANNE One captures ECG, heart rate, respiratory rate, SpO₂, pulse rate, skin temperature, body position, activity, and falls.
ANNE One captures ECG, heart rate, respiratory rate, SpO₂, pulse rate, skin temperature, body position, activity, and falls.
Penumbra (NYSE:PEN) announced today that it received FDA clearance for its Thunderbolt thrombectomy platform for stroke.
Subtle Medical has announced FDA clearance for SubtleHD(CT), an AI-powered image enhancement solution designed to reduce noise and improve low contrast detectability across CT imaging
The planned trial is expected to include 300 participants across two treatment arms.
The sensor expands Glean into wireless, catheter-free multi-channel urodynamics, targeting more comfortable and real-world bladder function testing.
Karl Storz announced today that it received FDA clearance for the digital, camera-based Rubina Lens exoscope for open surgery.
PARSIPPANY, N.J., June 9, 2026 /PRNewswire/ — Onkos Surgical, a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic conditions, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for the application of its NanoCept Antibacterial Technology on titanium implants within the ELEOS Limb Salvage System.
Designed for spinal fusion surgery, Lux is designed to increase the chances of procedural success and provide greater flexibility once implants are fitted.
W.L. Gore & Associates announced today that it received CE mark approval for its Viabahn Fortegra venous stent system.
EBR Systems said today that a new Medicare National Coverage Determination (NCD) will evaluate its leadless endocardial pacing technology.