FDA clears AI-powered ultrasound guidance tech from UltraSight

UltraSight, a Tel Aviv, Israel-based company, has received FDA clearance for its revolutionary AI-powered ultrasound guidance technology. The real-time AI guidance software is designed to aid in the acquisition of cardiac ultrasound images, making it particularly valuable for medical professionals without sonography experience in various care settings. With this technology, UltraSight aims to enhance heart disease detection, ensuring easier access to cardiac monitoring for patients.

Davidi Vortman, CEO of UltraSight, highlighted that the company was driven by the pressing need to address the imbalance between the number of heart disease patients and the availability of cardiac ultrasound services. By incorporating deep geometrical machine-learning techniques into cardiac ultrasound, they discovered that AI has the potential to bridge the skill set gap, empowering medical professionals to acquire timely and accurate cardiac ultrasound images virtually anywhere.

Having secured FDA clearance, UltraSight is now ready to bring its innovation to the market, thereby advancing patient care for the millions in need.

The UltraSight AI-powered technology offers numerous benefits to hospital staff and patients alike. It allows hospital staff to improve patient triage and treatment with greater efficiency and clinical confidence. Additionally, it brings cardiac ultrasound to local communities, increasing access to care for chronic heart disease patients, which can enhance patient adherence to crucial treatments.

The FDA clearance specifically covers the use of the UltraSight solution in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It grants authorisation for the acquisition of the 10 standard views of the heart. Clinical data has demonstrated that medical professionals without prior ultrasound experience can acquire diagnostic-quality images with real-time guidance of the ultrasound probe and feedback on image quality.

UltraSight's software is designed as an accessory for point-of-care ultrasound systems, and it is compatible with the Philips Lumify ultrasound system. By utilising an underlying AI network, the software predicts the position of the ultrasound probe relative to the heart based on the ultrasound video stream. It then guides the user on manoeuvring the probe to capture high-quality diagnostic cardiac images. With this technology, UltraSight aims to revolutionise cardiac care and improve patient outcomes significantly.

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