Regulatory

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

– 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 […]

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 […]

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 […]

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 […]