FDA clears Us2.ai's decision-support tool for echocardiography

Us2.ai announced Tuesday that the FDA has cleared its Us2.v1 imaging processing software, making it the first fully-automated solution measuring both two-dimensional (2D) and Doppler cardiac ultrasound images to produce "complete" patient reports needed for diagnosis, prediction and prognosis of heart disease. The artificial intelligence (AI)-based tool is now available for clinical use in the US.

"With this release, we've moved the field of AI beyond just a narrow feature for echocardiography, to a complete decision-support solution for cardiologists and primary care providers," remarked CEO James Hare. He noted that Us2.v1 eliminates "manual workflows and the lack of transparency from...'black box' AI approaches, creating a complete and fully-automated patient report with editable annotations, conclusions and comparisons to international reference guidelines."

23 automated measurements

The tool enables 23 echo parameters, including 2D, M-mode, spectral and tissue Doppler, covering the majority of standard measurements for adult transthoracic echocardiography recommended by major medical associations. According to Us2.ai, these measurements were shown to be both "completely interchangeable with expert human measurements…[and] reproducible for a given patient study, with an image processing/analysis algorithm computation time of around two minutes per study."

The company indicated that Us2.v1 will help to speed up diagnosis of diseases such as pulmonary hypertension and heart failure, especially in light of a recent deal to integrate its software into EchoNous' Kosmos handheld imaging tool, a move intended to allow machine learning-enabled analysis of heart scans.

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