Rivanna Medical’s Accuro Snags FDA Clearance
Rivanna Medical has won FDA 510(k) clearance for Accuro, a handheld device that guides a medical professional when using a needle or probe to reach a target inside the human body, the Charlottesville, Va., devicemaker announced Monday. It is the company’s first product.
The device works by using 3D navigation software to reduce guesswork when finding a target. Though it was indicated for spinal anesthesia needle guidance, and is the first ultrasound system designed specifically for that purpose, the company believes the product can be featured in a variety of other applications.
John A. Williams, president and CEO, says Accuro is a game-changer in the medical device industry given the unmet need for automated image guidance in general and spinal anesthesia in particular. Potential future indications for the device include diagnostic imaging for cardiac and abdominal anatomies.
Rivanna Medical is in discussions with corporate partners for a U.S. market launch.
There are more than 20 million epidural and spinal procedures conducted in the U.S. each year. — Jason Scott