Rivanna Medical said it has won FDA 510(k) clearance for its Accuro handheld needle guidance device indicated for spinal anesthesia.
The system provides 3D navigation for needle insertions to improve clinician accuracy in placement, the Charlottesville, Va.-based Rivanna Medical said.
“Because there are numerous clinical uses for Accuro, we believe it is a disruptive, game-changing device platform technology. The Accuro platform, which is based on automated 3D navigation, has an addressable $1.1 billion U.S. market today. Given the significant unmet clinical need for automated image guidance in general, and the spinal anesthesia market in particular, we are talking with potential strategic partners in order to accelerate U.S. market launch,” CEO John Williams said in a press release.
Blind needle guidance can lead to failed spinal anesthesia, Rivanna said. Of the over 20 million epidural and spinal anesthesia procedures per year, over 20% fail, the company said.
Last month, Rivanna Medical said it named Dr. Brendan Carvalho of the Stanford University Medical Center to its clinical advisory board.