The hand-held ultrasound developer Exo has launched two new FDA-cleared artificial intelligence applications tied to its pocket-sized Iris probe, which made its own debut last fall.
The latest green lights add cardiac and lung-focused programs to the company’s bladder, hip and thyroid scanning options—to offer automatic estimations of a patient’s heart ejection fraction at the point-of-care, as well as image capture guidance for catching the signs of pneumonia or pulmonary edema.
“It’s time for a reimagined approach to addressing heart failure at scale,” Exo co-founder and CEO Sandeep Akkaraju said in a statement. “That’s why Exo is putting AI-empowered medical imaging in the hands of every caregiver, no matter their specialty.”
In addition, the smartphone-connected Iris now features pulsed-wave Doppler imaging capabilities to highlight the velocity of blood as it moves through the body.
Exo’s previous AI apps enabled bladder volume measurements as well as the identification of hip dysplasia and potentially cancerous thyroid nodules. The former Fierce 15 winner said it plans to double the number of 510(k) clearances from the FDA to 10 by 2025.
The company estimates that 6.7 million people in the U.S. are currently living with heart failure—where an echocardiogram is an essential part of a diagnosis, and traditionally is performed by a technician with specific training.
Its programs were developed in what the company has described as its “AI factory,” with over 100 million images stored in its repository, including tens of thousands from real-world exams taken at the point of care.
In an interview with Fierce Medtech earlier this year, Akkaraju said he hopes 2024 will be a “banner year” for Exo as it ramps up its production and sales teams.