Exo Wins FDA Nod for AI Indicator for HFpEF and Cardiotoxicity

Exo, a company focused on artificial intelligence (AI)-powered, accessible medical imaging has gained another U.S. Food and Drug Administration (FDA) 510(k) clearance for its Exo Iris ultrasound—Global Longitudinal Strain (GLS) analysis.

SweepAI-based GLS auto-quantification provides objective data to help spot heart failure and chemotherapy-induced cardiotoxicity in seconds, according to the company. This FDA nod marks Exo’s 10^th FDA-cleared AI application and makes Iris the first, only handheld ultrasound with real-time, on-device GLS.

GLS is an indicator for myocardial dysfunction earlier than ejection fraction (EF) and before symptoms arise. It’s especially crucial to detect Heart Failure with preserved Ejection Fraction (HFpEF)—now over half of all heart failure cases—and for monitoring cardiotoxicity in oncology patients undergoing chemotherapy.

“This clearance represents a new era for point-of-care cardiac diagnostics,” said Sandeep Akkaraju, CEO of Exo. “With ten FDA-cleared AI indications, we’re delivering powerful, real-time insights where and when clinicians need them most.”

“We’re putting an entire suite of AIs—from GLS to EF to pulmonary congestion—right at clinicians’ fingertips,” added Arun Nagdev, MD, VP of Clinical Affairs at Exo and a leading POCUS expert. “With Exo Iris and SweepAI, providers can make high-confidence decisions in real-time, no matter where they practice. It’s a game changer for point-of-care medicine.”

Adding GLS gives Exo a complete heart failure AI suite on the Exo Iris device:

• HFpEF: AI for Instant GLS analysis for early indication of HFpEF and cardiotoxicity.
• HFrEF: Real-time AI EF assessment for systolic heart failure.
• ADHF: AI to detect signs of pulmonary vascular congestion in seconds.