Sonavex Wins FDA Nod for EchoMap AI-Powered Ultrasound Tech

Sonavex, a company focused on ultrasound tech that delivers quantitative blood flow and critical vascular data at the point of care, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its EchoMap device.

EchoMap uses 3D ultrasound and artificial intelligence (AI) algorithms to assist dialysis techs without prior ultrasound experience to visualize the target fistula or graft before cannulation.

Dialysis patients with arteriovenous fistulas or grafts require three times per week to facilitate blood filtration. Due to depth, tortuosity, and/or size, many fistulas are difficult to cannulate blindly with standard techniques. These challenges result in frequent needle misplacement, which leads to serious and expensive complications.

Conventional ultrasound has shown the ability to reduce catheter time, infection rates, the number of failed cannulation attempts, and associated costs in the hands of expert users. Complexity, training requirements, and other factors currently limit ultrasound’s use in dialysis clinics.

EchoMap instantly images in the coronal plan, offering a top-down view. Cannulators can view the position and path of the fistulas as if they could see it through the skin, without needing image interpretation.

3D imaging allows a full view of target anatomy without needing users to hold the transducer is a specific position or orientation. Automation also reduces the learning curve for ultrasound so techs can operate the device with minimal training, Sonavex said.

Later this year, Sonavex will kick-off a post-market study with a large dialysis organization (LDO), supported with funding from the National Institutes of Health (NIH).

“With FDA clearance in hand, we are excited to begin evaluating EchoMap in the hemodialysis clinic,” said Dr. Randy Cooper, principal investigator of the study. “This device offers real promise to reduce cannulation complications and associated fear and stress for our patients.”

Sonavex closed a $15 million Series A-2 financing round in November 2024 to support continued evidence development of its EchoMark and EchoSure technologies.