The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Rebound Therapeutics® Corporation today announced FDA 510k clearance of their AURORA Surgiscope® System, the world’s first single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy. The Aurora Surgiscope System consists of two components: the sterile, single use, neurological endoscope called the Aurora Surgiscope […]
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 […]
In April of 2017, we launched Verily Study Watch, an investigational device for capturing health information from clinical research participants while serving as an easy-to-read watch for daily wear. Since then, Study Watch has been used by thousands of participants in clinical research studies run by Verily and through our partners, such […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
