Sonavex announced that it received FDA 510(k) clearance for its AI-enabled EchoMap device with 3D ultrasound capabilities.
EchoMap uses 3D ultrasound and AI algorithms to enable dialysis technicians to visualize the target fistula or graft before cannulation. It can empower dialysis technicians without prior ultrasound experience to achieve this visualisation.
Related: Vivasure wins CE mark for bioresorbable PerQseal Elite device
The Baltimore, Maryland-based Johns Hopkins spinout says EchoMap makes ultrasound available to everybody. It instantly images the coronal plane, providing a top-down view for technicians. Cannulators can then see the position and path of the fistulas as if they could view it through the skin without the need for image interpretation.
Sonavex says 3D imaging enables a full view of target anatomy. It does this without requiring the user to hold the transducer in a specific position or orientation. Automation then reduces the learning curve for ultrasound, the company says. This allows technicians to confidently operate the device with minimal training.
Later this year, Sonavex plans to begin a post-market study with a large dialysis organization. It said the National Institutes of Health (NIH) will provide funding for the study.
“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.”
EchoMap is the latest in a portfolio of ultrasound-enabled devices developed by the company. Sonavex also develops the EchoMark and EchoSure technology platforms. EchoMark and EchoSure enable medical professionals to collect essential vascular parameters in the dialysis clinic to support AV fistula maturation assessment. The ultrasound technologies deliver quantitative blood flow and other critical vascular data at the point of care.
