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The company now has FDA 510(k) clearances on five applications: cardiac, lung, bladder, hip, and thyroid.
April 24, 2024
By: Sam Brusco
Associate Editor
Exo has rolled out its U.S. Food and Drug Administration (FDA)-cleared cardiac and lung artificial intelligence (AI) applications on its Exo Iris handheld ultrasound. The company now has FDA 510(k) clearances on five applications: cardiac, lung, bladder, hip, and thyroid. Exo said it plans to double the number of clearances by next year. Exo’s latest AI capabilities allow health systems and caregivers—especially those in rural or under-resourced settings—to use Exo Iris to simplify obtaining and interpreting medical images specific to the heart and lungs. The AI applications are trained on over 100,000 images from point-of-care ultrasound (POCUS) exams in real-world settings. The AI, according to the company, recognizes internal landmarks on less-than-perfect scans so real-time data can be used to make informed decisions without needing lab-quality ultrasounds. With a quick scan, Exo’s lung AI reliably identifies the presence of B-lines, enabling users to quickly assess if the patient has pulmonary edema. Both expert and early POCUS users can use Exo’s cardiac AI to quickly measure left ventricle ejection fraction (LVEF) and stroke volume in a few heartbeats in both parasternal long axis (PLAX) and apical four-chamber (A4C) views. In addition to cardiac and lung AI, Exo Iris now features Pulsed-Wave Doppler capabilities to provide physicians with even more opportunities to look at blood velocity. “It’s time for a reimagined approach to addressing heart failure at scale. That’s why Exo is putting AI-empowered medical imaging in the hands of every caregiver, no matter their specialty,” said Sandeep Akkaraju, co-founder and CEO of Exo. “Exo’s AI is simple to use, reproducible and objective, and will contribute to more accessible and reliable healthcare for all.”
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