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.
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.”
Research and development efforts reported in this press release were supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK131644. The content in this release is the sole responsibility of the authors and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.
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 www.sonavex.com.
Media Contact:
Sonavex, Inc.
Email: contact@sonavex.com
Phone: (443) 862-2024
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