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FDA Grants Clearance for AI Cardiac Ultrasound Technology


UltraSight says the technology allows for more widespread detection of heart disease.

UltraSight announced that the FDA granted clearance for it AI-powered ultrasound technology.

The software provides real-time guidance for HCPs for acquiring ultrasound images in multiple settings. Medical professionals without sonography experience can still use the software, providing more opportunities for the detection of heart disease.

In a press release, UltraSight’s CEO Davidi Vortman said, “The issues arising from the disproportion between the number of heart disease patients and availability of cardiac ultrasound was a key driver for the company's founding team. The need to solve this significant disparity is why we applied deep geometrical machine-learning techniques to cardiac ultrasound, and what we found is that AI has the potential to close the skillset gap–empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. With FDA clearance, we can now move forward with bringing our innovation to market and ultimately advancing patient care for the millions in need."

The software is designed to be used for two-dimensional transthoracic echocardiography in adult patients and can be used to assist in obtaining the 10 standard views of the heart.

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