Sonavex’s EchoMark Soft Tissue Markers Receive FDA 510(k) Clearance

Frank
December 16, 2018
24 Views

One year ago, we spoke with Sonavex CEO David Narrow about the Baltimore medical startup’s recent round of investment and ongoing development of its EchoMark and EchoSure products. At the time, David mentioned that the company was, “…preparing to submit our regulatory clearance materials.” This week, the company announced that it had secured FDA 510(k) clearance to market both EchoMark and EchoMark LP (low profile) soft tissue markers.

This is the first product from Sonavex to receive FDA clearance and represents an important inflection point for the business. “Regulatory clearance is a significant milestone in Sonavex’s mission to bring novel point-of-care medical imaging solutions to patients for improved surgical outcomes,” David commented on the announcement. “We believe that surgical ultrasound is an underutilized tool with the potential to dramatically change patient management – for the better,” added Dr. Devin O’Brien Coon, Sonavex President and Director of the 510(k) study. The company also recently received a Small Business Innovation Research (SBIR) Phase II supplement grant from the National Science Foundation (NSF) to support ongoing research and development efforts.

Sonavex’s soft tissue markets are echogenic, resorbable polymeric implants with uncommon reflective characteristics under ultrasound and a unique shape. These properties help precisely mark surgical sites for ultrasound imaging during follow-up evaluations of procedures such as vascular anastomoses.

Flashback: Ultrasound Technology Startup Sonavex Raises $3M Series A and Expands Board: Medgadget Interview…

Link: Sonavex homepage…

Via: Sonavex…

Frank’s source: https://www.medgadget.com/2018/06/sonavexs-echomark-soft-tissue-markers-receive-fda-510k-clearance.html

 

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