Singapore’s Medtech receives CE mark for automated cardiac ultrasound

Singapore-based Medtech company is expanding into Europe after receiving the CE mark for automated decision support tools for echocardiography.

Us2.v1 software is an automated clinical workflow solution that identifies and analyzes two-dimensional and Doppler echo images for the diagnosis, prognosis and prognosis of heart disease and pulmonary hypertension. The company claims that its software can process and analyze images for “about two minutes” and then provide a fully automated echo report with measurements, editable notes and conclusions for each chamber of the heart.

With this announcement, stated that it has received a notice of allowance from the United States Patent and Trademark Office, which is close to being officially patented for Us2.v1.

Why it matters

A A validation study for the Us2.v1 workflow concludes that the use of deep learning algorithms to automatically process 2D and Doppler echo images can achieve similar accuracy to manual measurements made by expert sonographers. The study, published in the Lancet Digital Health Journal, further noted that the use of automated workflows could “accelerate access, improve quality and reduce costs” in diagnosing and managing global heart failure. According to the World Health Organization, cardiovascular diseases claim approximately 38 million lives or approximately 38% of the worldwide recorded deaths each year.

Greater trend

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

In April, the company completed a রা 15 million series funding round led by IHH Healthcare and Hell Partners. Proceeds from the investment round are being used for its clinical implementation across the United States, Europe and Asia, and to build partnerships with pharmaceutical firms, research labs and imaging providers.

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