April 23, 2024 SANTA CLARA, Calif.--(BUSINESS WIRE)--Exo® (pronounced “echo”), a medical imaging software and devices company, today announced its FDA-cleared cardiac and lung artificial intelligence (AI) applications are now available on Exo Iris™, Exo’s high-performance handheld ultrasound device.

With affordable, AI-powered medical imaging in a pocket-sized device, caregivers can get to answers immediately to accelerate diagnosis and create new care pathways for heart failure patients at the point of care. As an industry leader in AI, Exo now has FDA 510k clearances on five different applications—cardiac, lung, bladder, hip and thyroid—with plans to double the number of clearances by 2025.

Diagnosing Heart Failure at the Point of Care
The number of Americans with heart failure today is over 6.7 million and growing. This figure represents both a population health and financial crisis with annual healthcare spending ballooning to $240 billion by 2030*. While echocardiography is the cornerstone of heart failure diagnosis, it is costly and requires highly trained sonographers to use it. As a result, people go without medical imaging when and where they need it most.

AI-powered handheld ultrasound can lower the threshold for answers at the point of care, enabling access to simple and affordable medical imaging. With the launch of Exo’s latest AI capabilities, health systems and caregivers—particularly those in rural and under-resourced settings—can leverage Exo Iris to simplify the process of obtaining and interpreting medical images specific to the heart and lungs. As a result, caregivers can accelerate their patients’ diagnosis and treatment no matter where they are located.

"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.”

Delivering AI You Can Trust
Exo trains its AI applications on over 100,000 images from point-of-care ultrasound (POCUS) exams performed by users in real-world settings, including emergency rooms and critical care units. As part of the FDA clearance process, Exo’s AI was rigorously validated across various patient populations, health conditions and diagnostic scan types. Therefore, Exo’s AI recognizes internal landmarks even on less-than-perfect scans, enabling caregivers to gain the real-time data needed to make informed decisions without requiring lab-quality ultrasounds.

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