SPAIN- Israeli cardiac imaging company UltraSight, has announced that its AI guiding software for cardiac ultrasound now carries the CE Mark.
The digital health pioneer received the CE Mark after findings validated its technology and showed that the software is effective in guiding inexperienced medical practitioners to create diagnostic-quality heart images.
According to the study, medical personnel without prior sonography training were able to obtain cardiac pictures of diagnostic quality from 100% of patients thanks to UltraSight AI assistance.
The Philips Lumify ultrasound system was used to conduct the study which was done at the Sheba Medical Center in Israel.
A product that has the CE mark means that the maker has evaluated it and determined that it complies with EU safety, health, and environmental protection standards.
Products made anywhere around the globe and marketed in the EU must comply with it.
Only products for which EU specifications exist and mandate the application of CE marking are subject to the requirement.
This landmark achievement paves the way for increased patient access to cardiac imaging and optimized care across Europe in 2023.
The milestone for UltraSight coincides with the European Society of Cardiology (ESC) Congress in Barcelona and its call for action to attain heart health in Europe by 2025.
The company’s technology can be applied at the point of care, opening the door for greater access to optimum cardiac treatment across the continent as well as more broad identification of cardiovascular illnesses (CVD).
Current point-of-care ultrasound machines are compatible with innovative AI software, which gives the user real-time directions on how to take excellent diagnostic images.
For adult patients undergoing two-dimensional transthoracic echocardiography (2D-TTE), the UltraSight AI Guidance program is recommended.
This landmark achievement paves the way for increased patient access to cardiac imaging and optimized care across Europe in 2023.
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