Johns Hopkins spinout Sonavex received clearance from the U.S. Food and Drug Administration (FDA) for a system that delivers data on blood flow following surgery, said CEO David Narrow.
EchoSure received 510(k) regulatory clearance, which is required to market medical devices in the U.S. Narrow called it a “critical milestone” for the Canton-based medical device startup, on March 8.
“The Sonavex team worked tirelessly for more than five years to create a solution that enables surgeons and nurses to easily collect vital information in real-time so they can provide the best results for their patients,” Narrow said.
EchoSure is designed to automate the process of monitoring blood flow after vascular surgery, which treats diseases of the arteries and veins. It utilizes ultrasound imaging and deep learning algorithms to provide both visual and quantitative data, and detect whether there is a loss of blood flow, indicating compromised blood vessels. An app also allows monitoring from a mobile device.
FDA clearance is a key point for startups looking to bring new technology to the healthcare market, as the regulatory agency must review safety and effectiveness of a product before it can be legally sold. This is the second FDA clearance for the Canton-based startup in a year. In June 2018, Sonavex received clearance for tiny implants called EchoMark. These ultrasound-detectable devices “mark” a site where surgery was performed, and the system takes into account its location and the angle from which it is viewed.
With the clearance for Echosure, the company now has FDA clearance for the full system team members set out to design, Narrow said. The two products can work together to create a solution that does not require expertise in ultrasound to use, according to Sonavex; adding the data provided by the company’s technology could allow earlier detection of issues such as blood clots before they lead to bigger complications.
The company now plans to ramp up commercialization efforts this spring. Narrow said John Berry, who previously worked with companies including Salient Surgical/TissueLink Medical through its $525 million acquisition by Medtronic, recently joined the company as vice president of sales and marketing. The company will continue to grow its team of nine full-time and five part-time employees in sales and marketing, as well as in engineering, where there is currently one opening.
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