Canton-based medical device startup Sonavex received clearance from the U.S. Food and Drug Administration to market implantable devices to be used with ultrasound imaging, CEO David Narrow said.
The 510(k) clearance means the Johns Hopkins spinout startup has regulatory approval for its initial product. The Echomark devices are designed to be used during a follow-up evaluation after surgery is completed.
The tiny implants are used to “mark” a soft tissue site in the body where surgery has been performed. When used with ultrasound, they provide an image to help assess the area where the operation took place, or determine whether additional procedures are necessary. The company says its devices have a unique shape and properties enabled by a manufacturing technique that allows for precise marking that provides a clear visual.
Narrow said the FDA clearance is a “significant milestone.” Going forward, the company plans to introduce the Echomark in a focused pilot at several hospital sites, and gather data as the devices are used in humans ahead of a full launch.
“After four years of development and testing, we are excited to start using EchoMark at the bedside,” Sonavex President Devin O’Brien Coon said in a statement. “We believe that surgical ultrasound is an underutilized tool with the potential to dramatically change patient management – for the better.”
According to Narrow, this won’t be the last FDA submission for the company. Sonavex is also developing a system, called Echosure, that uses ultrasound to automatically detect blood clots that will require separate clearance. The implants may be used independently, or with the new system. Additional products using ultrasound are also in development, Narrow said.
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