Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System.
Regulatory
Medtronic receives approval for Symplicity Spyral™ Renal Denervation System in Japan
Japan is now the 77th country to receive regulatory approval for the Symplicity Spyral Renal Denervation System Medtronic, a global leader in healthcare technology, today announced it received approval in Japan from the Pharmaceuticals and Medical Devices Agency (PMDA) for its Symplicity Spyral™ renal denervation (RDN) system, also known as […]
Catheter Precision Receives Approval for LockeT in the United Kingdom
FORT MILLS, S.C., Aug. 18, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced registration and approval in the United Kingdom for its LockeT product, a suture retention device. LockeT received CE Mark for European approval and distribution in May 2025. Obtaining registration was the final approval required to launch sales in the UK.
Instylla Gains U.S. FDA Premarket Approval for Embrace™ Hydrogel Embolic System
First and Only Liquid Embolic Approved for Hypervascular Tumor Embolization Supported by a Prospective, Randomized, Controlled, Clinical Trial BEDFORD, Mass., Aug. 7, 2025 /PRNewswire/ — Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular…
Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System
The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation MARLBOROUGH, Mass., July 7, 2025 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to…
InspireMD Announces CE Mark Approval for CGuard® Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
MIAMI, June 13, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS.
Foldax Secures Approval for TRIA Mitral Heart Valve in India
SALT LAKE CITY–(BUSINESS WIRE)–Foldax® Inc., a leader in heart valve innovation, today announced that the Indian Central Drugs Standard Control Organization (CDSCO) approved its TRIA™ Mitral Valve. Dolphin Life Science India LLP will locally manufacture the TRIA Mitral Valve in India. Foldax’s vision for its novel polymer heart valves is […]
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed for Seamless Integration with Hospital EHR Systems
FDA Grants De Novo Clearance for Reflow Medical’s Spur® Peripheral Retrievable Stent System
San Clemente, CA – May 29, 2025 – Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System a unique clinical solution for the treatment of […]
ZYLOX Unicorn™ Vascular Closure Device Receives Regulatory Approval in Indonesia
HANGZHOU, China, May 26, 2025 /PRNewswire/ — Zylox-Tonbridge Medical Technology Co., Ltd. (“Zylox-Tonbridge” or the “Company”) today announced that its proprietary ZYLOX Unicorn™ Vascular Closure Device (VCD) has received regulatory approval in Indonesia. This marks the ZYLOX Unicorn™…
Recent
Hone Health Integrates Prenuvo Whole-Body MRI Scans to Power Preventive, Data-Driven Longevity Care
XCath Endovascular Robotic System Successfully Performs its First-In-Human Brain Aneurysm Procedures
First Clinical Investigation of a Gene Therapy (YAP101) to Induce Cardiac Regeneration to Treat Heart Failure Passes Initial Safety Hurdle
Popular
- No commented posts yet