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 […]