Sonavex Receives FDA 510(k) Clearance for EchoMap™ Device
Baltimore, MD (April 28th, 2025) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s EchoMap™ device. Sonavex’s EchoMap leverages 3D ultrasound and AI algorithms to empower dialysis technicians without prior ultrasound experience to visualize the target fistula or graft before cannulation.
Dialysis patients with arteriovenous fistulas or grafts require cannulation (insertion of two large needles) 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 such as hematoma, infection, and aneurysm formation [1,2].
In the hands of expert users, conventional ultrasound has demonstrated the ability to reduce catheter time, infection rates, the number of failed cannulation attempts, and associated costs [3,4]. However, complexity, training requirements and other factors currently limit the use of ultrasound in dialysis clinics.
EchoMap makes ultrasound accessible to everyone by instantly imaging in the coronal plane, providing a top-down view for technicians. Cannulators can see the position and path of the fistulas as if they could view it through the skin, without the need for image interpretation. 3D imaging enables a full view of the target anatomy without requiring the user to hold the transducer in a specific position or orientation. Automation reduces the learning curve for ultrasound, allowing technicians to confidently operate the device with minimal training.
