FDA Clears Cardiac and Lung AI Applications for Exo Iris Handheld Ultrasound

The Food and Drug Administration (FDA) has granted 510(k) clearance for the addition of cardiac and lung artificial intelligence (AI) applications for the Exo Iris handheld ultrasound device.

With rapid identification of B-lines, the lung AI application allows quick detection of pulmonary edema, according to Exo. Whether one is utilizing parasternal long axis (PLAX) or apical four-chamber views, Exo said the cardiac AI application enables clinicians to ascertain stroke volume and measure left ventricle ejection fraction (LVEF) in seconds.

Emphasizing that the AI applications have been trained over 100,000 ultrasound images, including point-of-care images taken in critical care units and emergency room settings, Exo maintained that the cardiac and lung AI applications provide real-time recognition of key imaging landmarks, even with less than perfect scans.

“Exo’s cardiac and lung AI applications are a game-changer,” said Ted Koutouzis, M.D., a clinical instructor in emergency medicine at Northwestern Medicine in Chicago. “Now I have a fast and reliable clinical tool to help easily distinguish between COPD and CHF patients for precise and timely care.”