Singaporean medtech Us2.ai gets CE mark for automated cardiac ultrasound software

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Singapore-based medtech company Us2.ai is expanding to Europe after receiving a CE mark for its automated decision support tool for echocardiography.

The Us2.v1 software is an automated clinical workflow solution that identifies and analyses two-dimensional and Doppler echo images for the diagnosis, prediction, and prognosis of heart disease and pulmonary hypertension. The company claims that its software can process and analyse images for “approximately two minutes,” and then deliver a fully automated echo report with measurements, editable annotations, and conclusions for every chamber of the heart. 

Along with this announcement, Us2.ai said it also received a notice of allowance from the United States Patent and Trademark Office, inching closer to having its patent for Us2.v1 formally registered. 

WHY IT MATTERS

A validation study for the Us2.v1 workflow concluded that the use of deep learning algorithms to automatically process 2D and Doppler echo images can attain similar accuracy to manual measurements made by expert sonographers. The study, published in the Lancet Digital Health journal, also noted that the use of automated workflow might “accelerate access, improve quality, and reduce costs” in diagnosing and managing heart failure worldwide. According to the World Health Organization, cardiovascular diseases claim around 18 million lives globally each year or an estimated 38% of all recorded deaths worldwide.

THE LARGER TREND

The CE marking follows a string of approvals for clinical use that Us2.ai has received in the past years, including from the US Food and Drug Administration in 2021 and the Health Sciences Authority in Singapore early this year. The Us2.v1 software is also available for use in Canada, the United Kingdom, Australia and New Zealand.

In April, the company completed a $15 million Series A funding round led by IHH Healthcare and Heal Partners. The proceeds from the investing round are being used for its clinical implementations across the US, Europe, and Asia and for building partnerships with pharmaceutical firms, research labs, and imaging providers.



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