Breakthrough AI Indicator for HFpEF and Cardiotoxicity Added to Exo Iris®

Exo unveils its 10^th FDA-cleared AI, delivering instant, on-device Global Longitudinal Strain (GLS) analysis — no cloud, no lag, no guesswork

SANTA CLARA, Calif.--(BUSINESS WIRE)--Exo (pronounced “echo”), the leader in AI-powered, accessible medical imaging, announced its latest FDA 510(k) clearance for Global Longitudinal Strain (GLS) analysis — now available directly on the Exo Iris® ultrasound device. This marks Exo’s 10th FDA-cleared AI application and makes Iris the first and only handheld ultrasound to have real-time, on-device GLS, giving clinicians instant, bedside cardiac insight. SweepAI™-based GLS auto quantification empowers clinicians with objective data to help detect heart failure and chemotherapy-induced cardiotoxicity in seconds.

GLS is a game-changing indicator for myocardial dysfunction earlier than ejection fraction (EF) and before symptoms appear. “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.” It’s especially vital for spotting 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 changes the landscape, where strain analysis is no longer confined to high-end echo labs.

“We’re putting an entire suite of AIs — from GLS to EF to pulmonary congestion — right at clinicians' fingertips,” said Arun Nagdev, MD, Vice President 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.”

A Complete AI Suite for Heart Failure

With GLS, Exo now has a complete heart failure AI suite right on the Exo Iris® device, leveraging Exo’s proprietary SweepAI™ and built for the front line:

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.

All Exo AI runs directly on Exo Iris®, eliminating lag, reducing costs, and enabling expert-level diagnostics in any setting. With ten FDA-cleared AI indications, Exo is setting a new standard in fast, accurate, and scalable point-of-care imaging.

Visit Exo’s website to explore these capabilities.

About Exo

Exo is redefining medical imaging with its high-performance ultrasound platform and AI-driven solutions, making advanced care accessible to everyone. Follow us @exoeffect on X, LinkedIn, Facebook, and Instagram.