Jupiter Endovascular wins FDA clearance for Vertex catheter
September 17, 2025
Jupiter Endovascular announced today that its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices.
Jupiter Endovascular announced today that its Vertex catheter received FDA 510(k) clearance for the insertion of endovascular devices.
Durham, NC — September 16, 2025 — SutureTech, a surgeon-founded medical device company focused on advancing soft tissue and tendon repair, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for RapidFix™, its flagship device.
WALTHAM, Mass., Sept. 16, 2025 /PRNewswire/ — Body Vision Medical, a global leader in AI-powered intraoperative imaging, is proud to announce that its LungVision AI-powered advanced imaging system has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) in India. This approval marks a significant milestone in the company’s mission to improve early and accurate lung cancer diagnosis worldwide.
BrainsWay (Nasdaq:BWAY) today announced the FDA granted expanded clearance for its Deep Transcranial Magnetic Stimulation system to include an accelerated treatment protocol for major depressive disorder and patients with comorbid anxiety symptoms.
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe.
Roche announced today that it received CE mark for the integration of its Accu-Chek SmartGuide CGM with the mySugr app.
Expanded indication provides patients with knee osteoarthritis with the benefits of Embosphere’s consistent, predictable, and effective clinical results
Novocure (Nasdaq:NVCR) announced today that it received regulatory approval in Japan for its Optune Lua wearable device.
Pulnovo Medical announced today that it received two FDA investigational device exemption (IDE) approvals for its technology.
Breakthrough approval supports home-based testing and strengthens access to care