Tag: 510K

Anumana Receives U.S. FDA 510(k) Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, Inc., a leading AI-driven health technology and nference portfolio company working in collaboration with Mayo Clinic, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. “Anumana’s […]

SurModics (SRDX) Nabs Global Approvals of .014″ Low-Profile PTA Balloon Dilation Catheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for […]

AUM CARDIOVASCULAR RECEIVES FDA CLEARANCE FOR REVOLUTIONARY DIAGNOSTIC HEART DEVICE

NORTHFIELD, MINNESOTA— AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,™ a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs. The reusable, non-invasive, radiation-free handheld device, which is now available in the United States, records sounds […]