Exo® Unveils FDA-Cleared AI Integrated with Exo Iris™ for Heart Failure Management

Wednesday, April 24, 2024

Exo®, a medical imaging software and devices company, has introduced FDA-cleared cardiac and lung artificial intelligence (AI) applications on Exo Iris™, their handheld ultrasound device. This advancement aims to offer affordable, AI-powered medical imaging, enabling caregivers to accelerate diagnoses and establish new care pathways for heart failure patients at the point of care. With FDA 510k clearances on five applications—cardiac, lung, bladder, hip, and thyroid—Exo plans to double the number of clearances by 2025.

The prevalence of heart failure in the United States exceeds 6.7 million people and continues to rise, posing both a public health and financial challenge. Traditional echocardiography, while crucial for diagnosis, is costly and requires specialized sonographers. This results in unmet imaging needs, especially in critical moments.

Exo's AI-powered handheld ultrasound lowers the barrier to obtaining answers at the point of care, making medical imaging simple and affordable. Exo Iris allows health systems and caregivers, including those in rural or under-resourced settings, to access and interpret cardiac and pulmonary images quickly, regardless of location. This facilitates faster diagnoses and treatments, improving patient care.

Emphasizes the need for a new approach to addressing heart failure at scale. By making AI-empowered medical imaging accessible to every caregiver, Exo aims to improve healthcare accessibility and reliability.

Rigorous FDA validation ensures the reliability of Exo's AI across different imaging conditions, even in suboptimal scan situations.

Applications enable clinicians to differentiate between cardiac and pulmonary conditions rapidly. The lung AI detects B-lines, aiding in the assessment of pulmonary edema, while the cardiac AI measures left ventricular ejection fraction (LVEF) and stroke volume, crucial for cardiac function assessment. These real-time insights empower clinicians to optimize patient care efficiently.

Emergency Medicine at Northwestern Medicine, commend the impact of Exo's cardiac and lung AI applications. These tools provide a fast and reliable means of distinguishing between conditions, enhancing diagnostic accuracy and expanding access to ultrasound technology.

Cardiac and lung AI, now features Pulsed-Wave Doppler capabilities, further enhancing its utility for assessing blood velocity in various applications.

This initiative underscores Exo's mission to revolutionize medical imaging by delivering simple, affordable solutions directly to the point of care.


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