Tissue markers receive FDA 510(k) clearance
Sonavex has announced that it received 510(k) clearance from the FDA to market its EchoMark and EchoMark LP soft tissue markers. EchoMark and EchoMark LP (Low Profile) are highly echogenic, resorbable polymeric implants used for marking soft tissue sites in surgical patients. EchoMark’s unique ultrasound reflective properties, created by a novel manufacturing technique, and 3D shape enable surgeons to precisely mark surgical sites for clear ultrasound visualisation during critical follow-up evaluations.
EchoMark is the first product in Sonavex’s growing portfolio of new technologies to receive FDA clearance. “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,” said David Narrow, CEO of Sonavex.
“This achievement is a testament to the strength of our team and commitment of our collaborators. We are pleased to bring EchoMark to market and look forward to further expanding our product line in the near future.”
“After four years of development and testing, we are excited to start using EchoMark at the bedside,” said Devin O’Brien Coon, MD, Sonavex President and Study Director for the pivotal 510(k) study. "We believe that surgical ultrasound is an underutilised tool with the potential to dramatically change patient management – for the better."
In addition to a recently closed Series A financing, last month the company was awarded a Small Business Innovation Research (SBIR) Phase II supplement grant from the National Science Foundation to support further research and development efforts for next-generation ultrasound technologies.