MedTech News

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.

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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.

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