The new solution allows for quick identification of hyperdense volumes to improve hemorrhage management SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, […]
Regulatory
Caption Health Receives CE Mark for Caption AI™ technology platform
Further milestone for company as it fulfills its mission to detect cardiac disease earlier in patients BRISBANE, Calif., July 19, 2022 /PRNewswire/ — Caption Health, the leader in using AI and services to improve heart ultrasound access, today announced that it has received […]
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 […]
FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics
First and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope OAKLAND, Calif., July 12, 2022 /PRNewswire/ — Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food […]
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 […]
Ra Medical Systems Receives FDA 510(k) Clearance for the DABRA 2.0 Catheter
Board of Directors continues its review of strategic alternatives to determine the Company’s optimal path forward CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system […]
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 […]