FDA Grants Clearance for NYU Startup UltraSight’s Cardiac Ultrasound Technology

NYU Startup UltraSight has been granted FDA clearance for its AI-powered ultrasound guidance technology. UltraSight’s AI guidance software assists medical professionals without sonography experience in acquiring cardiac ultrasound images, allowing for more widespread detection of heart disease and providing patients with easier access to cardiac monitoring. With this FDA clearance, the company can move forward with bringing this innovation to market and ultimately advancing patient care for millions in need.

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About UltraSight

Cardiovascular diseases are currently the number one cause of death globally according to the World Health Organization. Ultrasound imaging is an important noninvasive tool for detecting and diagnosing cardiovascular problems. However, capturing high-quality cardiac ultrasound images can be challenging, even for highly trained and experienced sonographers. There is a need for ultrasound in various care settings and in many regions around the world, but the lack of expertise in ultrasound image acquisition and interpretation presents a major barrier to wider use.

To develop a solution to this problem, Dr. Achiau Ludomirsky, pediatric cardiologist and professor at NYU Langone Health’s School of Medicine, teamed up with Itay Kezurer and Professor Yaron Lipman from the applied math and computer science department at the Weizmann Institute of Science in Israel. Combining their vision and expertise, they developed an algorithm that uses geometrical deep learning artificial intelligence (AI) to guide cardiac ultrasound image acquisition and provide image quality assessment. 

The AI software is paired with commercially available ultrasound devices. The ultrasound probe is attached to a standard tablet, and the AI software works as a sort of navigation system, providing real-time guidance so that users, even those with no sonography training, can easily acquire diagnostic-quality images. 

To commercialize the technology, NYU and Weizmann Institute of Science’s Yeda Research and Development Company co-founded the digital-health startup UltraSight, which is headquartered in Israel. NYU’s Technology Opportunities and Ventures worked with Yeda to provide seed funding for the project, file patents on the intellectual property, and negotiate the startup license. In August 2022, UltraSight obtained a CE mark for its software, and it is expected to be available on the European market in 2023.

The company received a CE Mark in August 2022 after results from a clinical study conducted at the Sheba Medical Center, Israel, which validated the technology and confirmed that the software is effective at instructing novice medical professionals to acquire diagnostic-quality cardiac images. The study found that UltraSight AI guidance allowed medical professionals who did not have prior sonography experience to obtain diagnostic quality cardiac images in 100 percent of patients. 

This novel software has the potential to change patient care in both in- and outpatient environments, empowering medical professionals to confidently capture cardiac ultrasound images, informing clinical decisions and treatment.