MedTech News
Zimmer Biomet wins CE mark for Persona Knee
Zimmer Biomet (NYSE:ZBH) announced today that it received CE mark approval in Europe for its Persona Revision Knee system.
THINK Surgical Receives FDA 510(k) Clearance for Use of LinkSymphoKnee (LSK) implants With TMINI Miniature Robotic System
FREMONT, Calif., Nov. 18, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the LinkSymphoKnee (LSK) from Waldemar Link GmbH & Co. KG, Germany (LINK) under a Collaboration Agreement between the two companies.
Solventum launches first 3D-printed dental aligner attachments
Solventum (NYSE:SOLV) announced today that it launched its 3M Clarity precision grip attachments for the 3M Clarity aligners.
Medtronic receives CE Mark for Endoflip system
Endoflip is an advanced diagnostic tool that can help expedite accurate diagnosis of oesophageal motility disorders, conditions often missed during endoscopies.
GE Healthcare’s head-only MRI scanner cleared by the FDA
The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.
Xeltis announces FDA Breakthrough Device Designation for aXessTM and first patient treated in US pivotal trial
EINDHOVEN, The Netherlands, Nov. 14, 2024 /PRNewswire/ — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted aXess Breakthrough Device Designation status. aXess is Xeltis’ vascular access conduit, which enables the creation of a new, permanent, living vessel for hemodialysis vascular access.
FDA authorizes the first AI-driven MRI solution for safer Alzheimer’s treatment
BOSTON and LEUVEN, Belgium, Nov. 14, 2024 /PRNewswire/ — Why this news will impact the lives of people affected by Alzheimer’s disease:
Eko Health Granted Category III CPT Code for SENSORA™ AI Heart Disease Detection Platform
SAN FRANCISCO, Nov. 14, 2024 /PRNewswire/ — Eko Health, a pioneer in applying artificial intelligence for early detection of heart and lung diseases, today announced the issuance of a Category III Current Procedural Terminology (CPT) code by the American Medical Association (AMA) for its SENSORA™ platform. The newly issued Category III CPT code will be effective on July 1, 2025, and is the first step to coverage and reimbursement for SENSORA™, bringing advanced heart disease detection to clinicians across the U.S.