UltraSight receives CE mark for cardiac AI technology

UltraSight receives CE mark for cardiac AI technology

UltraSight, an Israeli-based digital health pioneer transforming cardiac imaging through the power of Artificial Intelligence, has announced it has obtained a CE mark for its AI guidance software for cardiac ultrasound. This milestone comes just ahead of the European Society of Cardiology (ESC) Congress in Barcelona and aligns with its call for action to achieve heart health in Europe by 2025.

UltraSight’s technology allows medical professionals – regardless of their sonography experience – to successfully capture diagnostic quality ultrasound images of the heart. The technology can be used at the point-of-care, paving the way for more widespread detection of cardiovascular diseases (CVD) and improved access to optimised cardiac care across the continent.

The novel AI software pairs with point-of-care ultrasound devices that are currently on the market and provides the operator with real-time instructions on how to capture high-quality diagnostic images. The underlying AI neural network predicts the position of the ultrasound probe relative to the heart, based on the ultrasound video stream only and guides the user on how to manoeuvre the probe to ensure that the acquired images are of diagnostic quality.

“UltraSight was founded with the intention to apply the power of Machine Learning in imaging and put the ability to scan patients into the hands of physicians everywhere,” said Davidi Vortman, CEO of UltraSight.

“By empowering more medical professionals to accurately scan patients, we will have faster and greater detection of CVD across the continent. This is not only a momentous occasion for UltraSight as a company, but it brings us one step closer to helping the millions of people in Europe who suffer from CVD.”

According to the ESC, 113 million people are living with CVD in Europe today. Europe has the highest CVD mortality rate in the world, with approximately 4 million people succumbing to this disease each year. CVD is the leading cause of death for Europeans.

UltraSight obtained the CE mark after results from a clinical study held at the Sheba Medical Centre, Israel, validated its 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% of patients.

“Many medical residents have entered the healthcare field since the pandemic; however, being able to provide them with the necessary hands-on training and supervision has become challenging for many European emergency departments looking to adopt point-of-care ultrasound,” said Professor Salvatore Di Somma, MD, PhD, Director of Emergency Medicine and Chairman of the Postgraduate School of Emergency Medicine at the Department of Medical-Surgery Sciences and Translational Medicine University of Sapienza in Rome, Italy.

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