Three Studies Validate BVA-Guided Care Significantly Cuts Hospital Readmissions and Boosts Survival in High-Cost Heart Failure Segments
Regulatory
Pulnovo Medical Receives two IDE approvals for PADN system’s clinical trials with CMS coverage
SHANGHAI, Sept. 12, 2025 /PRNewswire/ — Pulnovo Medical, a globally recognized leader in medical devices for pulmonary hypertension (PH) and heart failure (HF), is proud to announce that its PADN catheter and generator has received two Investigational Device Exemption (IDE) approvals—HDE…
Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System
Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System.
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
Recent
January Issue of Journal of Cardiac Failure-Intersections Examines How Innovation, Advanced Mechanical Support, and Prescribing Design Are Reshaping Heart Failure Care
BioAge Announces Proposed Public Offering
Abbott receives CE Mark for the TactiFlex™ Duo Ablation Catheter to treat patients with abnormal heart rhythms
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