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UltraSight Receives CE Mark for Novel Cardiac AI Technology

Landmark achievement paves the way for increased patient access to cardiac imaging and optimized care across Europe in 2023

UltraSight, an Israeli-based digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced it has obtained a CE Mark for its AI guidance software for cardiac ultrasound. Today’s 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 optimized cardiac care across the continent.

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

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UltraSight obtained CE Mark after results from a clinical study held at the Sheba Medical Center, 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 percent of patients. The study was conducted using the Philips Lumify ultrasound device.

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“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 Prof. 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. “Supporting new ultrasound users with AI guidance, such as UltraSight’s AI guidance software, would increase efficiencies and expedite the learning curve while also reducing the time for obtaining good echocardiographic imaging in the Emergency Room, opening resources for experienced staff to respond to other acute needs.”

“Point of care ultrasound can be a very useful tool for Intensive Care Unit physicians. Some key hemodynamic measurements, such as Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI), provide invaluable help to guide fluid therapy. However, some physicians are still reluctant to use it because they consider this measurement a competence reserved for advanced ultrasound operators,” said Professor Bernard Cholley, ICU Department Head at the Hôpital Européen Georges Pompidou, Paris, France. “When introduced to UltraSight’s AI guidance software, we were very compelled by the prospect of AI supporting more healthcare providers, including novice ultrasound users, to acquire a cardiac ultrasound view by which the LVOT VTI can be measured accurately for a reliable measurement and optimized patient care.”

The UltraSight AI Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients. It is intended to assist medical professionals in performing cardiac ultrasound scans. UltraSight AI Guidance software is an accessory to compatible general-purpose diagnostic ultrasound systems and is intended to be used by medical professionals who have received UltraSight’s training as described in the user manual.

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