Tag: FDA

FDA Additionally Clears RAPID™ Imaging Platform for Use in Selecting Acute Stroke Patients for Clot Removal

MENLO PARK, Calif.–(BUSINESS WIRE)–iSchemaView, the worldwide leader in advanced imaging for stroke, today announced that the FDA has cleared the RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). Specifically, this additional clearance means that RAPID CT-Perfusion and RAPID MR-Perfusion […]

FDA Approves World’s First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect)

ABBOTT PARK, Ill., Jan. 14, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or […]

MRI Interventions Receives FDA Clearance for ClearPoint® PURSUIT™ Neuro Aspiration System

IRVINE, Calif., Jan. 03, 2019 (GLOBE NEWSWIRE) — MRI Interventions, Inc. (OTCQB:MRIC), a platform neurosurgery company with products designed for navigation in procedures involving deep-brain stimulation, ablation, and gene and drug delivery today announced FDA Clearance of the ClearPoint PURSUIT Neuro Aspiration system. The PURSUIT device was designed in collaboration […]

ARCA biopharma Updates Special Protocol Assessment Request to FDA for Gencaro Phase 3 Atrial Fibrillation Clinical Trial

WESTMINSTER, Colo., Dec. 20, 2018 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has submitted an amendment to its Special Protocol Assessment (SPA)request to the U.S. Food and Drug Administration (FDA).  The amendment addresses […]

CathWorks FFRangio™ System Receives U.S. FDA Clearance

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]

Cardiva Medical Announces FDA Approval of the VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures

SANTA CLARA, Calif.–(BUSINESS WIRE)–Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed […]

Hancock Jaffe Receives Approval for First-in-Human VenoValve Study

IRVINE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has received regulatory approval from INVIMA, the Colombian equivalent of the U.S. Food and Drug Administration, for its first-in-human […]

Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes’ Physician-Sponsored IDE

BELLEVUE, Wash.–(BUSINESS WIRE)–Aortica Corporation today announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study at the University of Washington (UW) sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes. The positive decision allows the use of Medtronic’s Valiant NAVION™ stent graft system […]

JenaValve Technology Receives FDA Approval for Expanded IDE Enrollment in the Treatment of Patients with Severe Aortic Stenosis and Severe Aortic Regurgitation

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and […]

Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery

ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of oxygen delivery as one of 12 critical blood parameters. Oxygen […]