Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system
March 14, 2024
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
The FDA created special controls that provide a path to market for other developers of over-the-counter devices.
SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial. The approved trial will evaluate the Company’s LIFT implant to treat later stage patellofemoral cartilage degeneration in adult patients.
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.
BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ — Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio previously received FDA 510(k) in the US and has now been cleared through Health Canada.
A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes
Element Science announced that it received CE mark approval for its novel patch-wearable cardioverter defibrillator (P-WCD).
The single-use, PEEK-based RIB System utilizes the platform technology of Able’s Valkyrie® Thoracic Fixation System, further strengthening Able Medical’s portfolio.
Intuitive Surgical (Nasdaq: ISRG)+
announced today that it received CE mark approval for its da Vinci SP surgical robot platform.