Ultrasound blood flow monitor gets FDA 510(k) clearanceMay 8, 2019
Sonavex received 510(k) clearance from the US FDA for its EchoSure device to deliver definitive blood flow data on demand.
The EchoSure system combines 3D ultrasound imaging with advanced deep learning algorithms to automate visual and quantitative blood flow monitoring after surgery. Coupled with EchoMark bioresorbable markers, EchoSure eliminates the need for ultrasound expertise in order to measure blood flow. The EchoSure App enables surgeons to monitor patients remotely from their mobile devices.
“Putting ultrasound technology in the hands of bedside nurses for the first time may enable detection of a vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes,” said Devin O’Brien Coon, MD, Chief Medical Officer and President of Sonavex.
EchoMark and EchoSure are both available from Sonavex for clinical use across the United States.