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 […]
Tag: 510K
EndoVantage Secures 510(k) Clearance from FDA for SurgicalPreviewTM
SCOTTSDALE, AZ – November 8, 2017 – EndoVantage, LLC, a pioneer in cloud-based medical simulation technology, today announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration for SurgicalPreviewTM, its preoperative planning system for the endovascular treatment […]
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” […]
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, […]