Tag: FDA

U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms

Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) […]

FDA Clears Caretaker Medical’s Wireless Monitor for NonInvasive & Continuous Cardiac Output, Stroke Volume, and Advanced Hemodynamics

VitalStream™, Featuring Patented Pulse Decomposition Analysis™ technology becomes the World’s First Wireless Wearable Monitor for Continuous Blood Pressure and Advanced Hemodynamics – All with a single, easy-to-apply Finger Sensor Caretaker Medical, a digital health leader in continuous “beat by beat” […]

BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021″ steerable microcatheter

TEL AVIV, Israel, April 18, 2022 /PRNewswire/ — BENDIT Technologies, a company focused on the development of a steerable microcatheter platform, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the […]

Israeli startup Sanolla receives FDA clearance for the world’s first AI-ready infrasound stethoscope

Sanolla’s pioneering technology draws lifesaving medical insights from listening to bodily sounds that cannot be heard by humans The startup’s AI algorithms provide unmatched disease classification for many cardiopulmonary diseases including COPD, pneumonia, asthma, and cardiac morbidities NESHER, Israel, April 11, 2022 /PRNewswire/ […]