FDA clears handheld ultrasound from Rivanna

Rivanna Medical has announced that Accuro, the company’s handheld ultrasound device, has received FDA 510(k) clearance and can now be marketed in the U.S.

Accuro is a smart phone-sized, untethered ultrasound platform designed specifically to guide spinal anesthesia with automated 3D navigation technology, according to Rivanna. It can also perform ultrasound imaging of abdominal, musculoskeletal, cardiac and peripheral vascular anatomies.

“The Accuro platform, which is based on automated superior imaging technology, has an addressable $1+ billion U.S. market today,” said John A. Williams, president and CEO of Rivanna, in a press release. “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 (ASA) in San Diego in just three months.”