The Latest Cardiac and Vascular News
First AI-powered cerebral aneurysm detection solution designed to facilitate population screening and enhanced care management SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the world leader in artificial intelligence (AI) powered care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM. The new algorithm uses AI to […]
Results of CTO-PCI IDE Study Demonstrate Procedural Success with Teleflex Specialty Catheters and Coronary Guidewires in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions WAYNE, Pa., Feb. 23, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and […]
On-site plant will produce DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms NORTH BILLERICA, Mass., Feb. 23, 2022 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial […]
– New expanded indication provides patients suffering from earlier stages of heart failure access to the CardioMEMS™ HF System, a small implantable sensor that can flag early warning signs of worsening heart failure – FDA approval was supported by data from the GUIDE-HF trial, which suggested that the CardioMEMS sensor […]
Family of focal ablation catheters are the only approved option to treat specific type of supraventricular tachycardia (SVT) DUBLIN, Feb. 18, 2022 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the Freezor™ and Freezor™ Xtra Cardiac Cryoablation Catheters are approved by the U.S. Food and Drug Administration […]
Niagara Falls, NY , Feb. 17, 2022 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a nuclear medicine PET imaging device systems and clinical services company, is pleased to announce today that the Company has retained Medical Device Academy ”MDA”) as its consultant for the Company’s new […]
– Phase 1/2 clinical trial expected to initiate in mid-2022 – – LX2006 is the first clinical-stage program from LEXEO’s cardiovascular pipeline and the third clinical-stage gene therapy candidate across its pipeline – NEW YORK, Feb. 16, 2022 (GLOBE NEWSWIRE) — LEXEO Therapeutics (LEXEO), a clinical-stage gene therapy company advancing a diverse […]
CHICAGO, Feb. 15, 2022 /PRNewswire/ — Cardiosense, Inc., a Chicago-based digital health company building a physiological waveform AI platform to manage cardiac disease, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify patients at risk of decompensated heart failure. The algorithm analyzes […]
Comaneci™ temporarily expands blood vessels–recognized as novel device for life-threatening disease YOKNEAM, Israel & MIAMI–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, today announced FDA breakthrough designation for its Comaneci™ embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke. Vasospasm is a major complication and cause of morbidity. […]
WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke. Asundexian is an oral inhibitor of Factor Eleven (FXIa) 1 that Bayer is developing […]
