Sonavex Receives FDA 510(k) Clearance for EchoSure
Medical device company receives second FDA clearance, adding blood flow monitoring technology to portfolio
“Putting ultrasound technology in the hands of bedside nurses for the first time may enable detection of vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes.” - Devin O'Brien Coon, MD, Chief Medical Officer
BALTIMORE (PRWEB) MARCH 11, 2019
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration 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 Sonavex’s FDA-cleared 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.
“For decades, the surgical community has sought a simple, fast and non-invasive way to accurately quantify blood flow after microvascular and vascular surgeries,” said Devin O’Brien Coon, MD, Chief Medical Officer and President of Sonavex and a board-certified plastic and microvascular surgeon at Johns Hopkins. “Putting ultrasound technology in the hands of bedside nurses for the first time may enable detection of vascular compromise earlier than clinical observation alone, providing opportunities for more rapid intervention and improved patient outcomes.”
This news follows within months of FDA clearance of Sonavex’s EchoMark device. “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,” said David Narrow, CEO of Sonavex. “This is a critical milestone in our mission to bring transformative ultrasound technologies to patients, and we are excited to ramp up commercialization efforts this spring.”
EchoMark and EchoSure are both available from Sonavex for clinical use across the United States.
About Sonavex, Inc.
Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. For more information, please visit http://www.sonavex.com.