Regulatory

Pulnovo Medical Concludes Successfully First Pre-Sub Meeting with FDA for PADN Global Clinical Trial

SHANGHAI, July 15, 2022 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized device pioneer in the treatment for cardiopulmonary diseases, today announced that it has successfully concluded the first Pre-Sub meeting with the U.S. Food and Drug Administration (“FDA”) for its Pulmonary […]

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Designation Allows for Expedited Review of Transcatheter Therapy Designed to Improve Left Ventricular Structure and Function in Heart Failure Patients with Reduced Ejection Fraction SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel device-based therapy to address heart […]

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a Phase 3 trial (The ASTER […]

LIVEMETRIC RECEIVES FDA CLEARANCE FOR ITS WATCH-LIKE WEARABLE BLOOD PRESSURE MONITORING TECHNOLOGY, A LONG-AWAITED REVOLUTION IN CUFF-FREE HYPERTENSION MONITORING

LiveMetric is launching LiveOne, an FDA-cleared wearable technology for health systems, health insurers, and self-insured employers to improve the care and treatment of people with hypertension and cardiovascular disease.  DENVER and LUXEMBOURG, June 30, 2022 /PRNewswire/ — LiveMetric, a leader in medical wearable technology, today announced the launch of […]

Clarius Introduces Partnership with ImaCor That Powers New FDA Cleared Handheld Hemodynamic Ultrasound

Now made ultra-portable with Clarius, ImaCor’s Zura Handheld Hemodynamic Ultrasound™ has received FDA clearance as the world’s first handheld transesophageal echocardiography (TEE) system, enabling more clinicians to accurately determine appropriate interventions in real-time. VANCOUVER, BC and JERICHO, N.Y., June 29, 2022 /PRNewswire/ — Clarius Mobile Health, […]

Acutus Medical Announces FDA Clearance, Commercial Launch of AcQCross™ Line Extension Compatible with Watchman™ Delivery System

Innovative Transseptal Access System Is First and Only to Feature Integrated Dilator and Needle to Reduce Exchanges CARLSBAD, Calif., June 27, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way […]