– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction – FDA approval marks a significant breakthrough for the approximately 3 million adults […]
Regulatory
FDA Approves Treatment for Wider Range of Patients with Heart Failure
SILVER SPRING, Md., Feb. 24, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as […]
Viz.ai Receives FDA 510(k) Clearance for Viz ANEURYSM
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) […]
Teleflex Receives FDA Clearance for Expanded Indication for Specialty Catheter and Coronary Guidewire Use in CTO PCI Procedures
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 […]
Lantheus Receives U.S. FDA Approval of New Manufacturing Facility
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 […]
Abbott’s CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure
– 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 […]
Medtronic receives FDA expanded approval for cardiac cryoablation catheters for pediatric treatment of a common heart rhythm condition
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 […]
Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application
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 […]
LEXEO Therapeutics Announces FDA Clearance of Investigational New Drug Application for LX2006, an AAV-based Gene Therapy Candidate for Friedreich’s Ataxia Cardiomyopathy
– 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) […]
Cardiosense receives FDA Breakthrough Device designation for algorithm to identify patients at risk of decompensated heart failure
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 […]