FDA Clears Rivanna Medical Ultrasound Device to Guide Spinal Anesthesia

Charlottesville, Va.-based Rivanna Medical LLC has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Accuro, a handheld and untethered smart phone-sized ultrasound device designed to guide spinal anesthesia with automated 3-D navigation technology in addition to ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies.

According to the company, the Accuro platform is designed to provide automated navigation to an anatomical target so a clinician may avoid guesswork when finding the target. The initial commercial application of Rivanna’s Accuro platform is designed for guiding clinicians to a first-attempt success in administering spinal anesthesia.

“There are multiple clinical uses for Accuro, a disruptive, game-changing device platform technology,” said John A. Williams, president and CEO of Rivanna Medical. “The Accuro platform, which is based on automated superior imaging technology, has an addressable $1 billion U.S. market today. Because of the considerable unmet clinical need for automated image guidance in general, and in the spinal anesthesia market especially, we are looking forward to launching Accuro at the upcoming annual scientific meeting of the American Society of Anesthesiologist in San Diego in just three months.”