Sonavex nets FDA OK for blood-flow device

Medical device firm Sonavex has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoSure ultrasound and artificial intelligence (AI) device, which delivers definitive blood-flow data on demand.

The EchoSure combines 3D ultrasound imaging with advanced deep learning algorithms to automate visual and quantitative blood-flow monitoring after surgery. When combined with the company's FDA-cleared EchoMark bioresorbable markers, EchoSure is designed to eliminate the need for ultrasound expertise to measure blood flow.

The EchoSure app also allows surgeons to monitor patients remotely from their mobile devices.

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