Imperative Care Announces FDA Clearance of Initial Products

CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc., a company singularly dedicated to finding answers to unsolved problems in stroke, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its first family of access catheters, designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke and other brain […]

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 […]

Euphrates Vascular announces FDA clearance of the ICHOR Reperfusion System 

St. Louis, Missouri – Euphrates Vascular (, a company focused on the treatment of vascular occlusions, recently received 510(k) clearance for sale of its ICHOR Percutaneous Reperfusion System. ICHOR is a Percutaneous Reperfusion System designed to treat organized thrombus and embolic events in the peripheral vasculature. ICHOR is a “one size fits […]

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 […]

Edwards’ SAPIEN 3 Ultra Transcatheter Heart Valve Receives FDA Approval

IRVINE, Calif., Dec. 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA) approval for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients […]

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 […]

Paragonix Technologies, Inc., Announces 510(k) Clearance Allowing for Use of the Paragonix SherpaPak™ Cardiac Transport System with Pediatric and Small Donor Hearts

BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that it received clearance by the Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak™ Cardiac Transport System (CTS)1,2 with small and pediatric donor hearts. Starting in Q1 2019, Paragonix SherpaPak™ CTS will now be shipped with […]