Route 92 Medical announces FDA 510(k) clearance for its FreeClimb 54 reperfusion system, part of its growing portfolio of neurovascular devices.
Regulatory
Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for vessels of the peripheral arterial and venous systems
PLEASANTON, Calif., April 22, 2024 /PRNewswire/ — Expanse ICE announced today the ICE Aspiration System has received 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new and exciting player in the peripheral thrombectomy market. The ICE…
Polymedco announces US FDA clearance of the PATHFAST high-sensitivity cardiac troponin I (hs-cTnI-II) test as an aid in the diagnosis of myocardial infarction
PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States, delivering results up to three times faster than core lab testing CORTLANDT MANOR, N.Y., March 27, 2024 /PRNewswire/ — The PATHFAST hs-cTnI-II, a breakthrough high-sensitivity…
Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access DUBLIN, March 27, 2024 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and…
Adagio Medical Announces CE Mark approval of VT Cryoablation System, Plans for Immediate Commercialization in Select European Centers
LAGUNA HILLS, Calif., March 25, 2024 /PRNewswire/ — Adagio Medical, Inc., a leading innovator in catheter ablation technologies for ventricular tachycardia (“VT”) and atrial fibrillation (“AF”), today announced CE Mark approval of its ultra-low temperature cryoablation (“ULTC”) system for the treatment of monomorphic ventricular tachycardia. The system consists of the upgraded cryoablation console, […]
Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE™ Platform for the Treatment of Paroxysmal Atrial Fibrillation
Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE™ Platform among U.S. patients IRVINE, Calif., March 25, 2024 /PRNewswire/ — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part…
Elixir Medical Receives FDA Breakthrough Device Designation for the DynamX BTK System for Use in the Treatment of Chronic Limb-Threatening Ischemia Resulting From Below-The-Knee Arterial Disease
MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of disruptive technologies to treat cardiovascular and peripheral disease, today announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX® BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The DynamX Bioadaptor platform is a medical technology d
PulseCath Achieves MDR CE Certification for iVAC 2L, Paving the Way for Complex High-Risk Percutaneous Coronary Interventions
ARNHEM, Netherlands, March 11, 2024 /PRNewswire/ — PulseCath B.V., a leader in the expanding field of percutaneous ventricular assist devices for high-risk PCI, proudly announces the successful achievement of the transition from Medical Device Directive (MDD) CE marking to Medical Device…
United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)
NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection […]
Cleerly® Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System
DENVER–(BUSINESS WIRE)–Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Coronary Artery Disease (CAD) Staging System. The CAD Staging System is a […]
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