06.01.15
Charlottesville, Va.-based Rivanna Medical LLC has earned 510(k) clearance for the Accuro, a handheld, untethered smart phone-sized device designed to guide a clinician using a needle or probe to a target within the human anatomy.
The Accuro device is designed to provide 3-D navigation to an anatomical target so a clinician may avoid guessing where the target is. The initial application of the Accuro device is for spinal anesthesia needle guidance.
“Because there are numerous clinical uses for Accuro, we believe it is a disruptive, game-changing device platform technology,” said John A. Williams, president and CEO. “The Accuro platform, which is based on automated 3-D 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.”
Spinal anesthesia often fails due to reliance on “blind” needle guidance. There are more than 20 million neuraxial anesthesia-related (epidurals and spinals) procedures per year in the United States. Twenty to 80 percent of all needle placement attempts fail, depending on operator skill, age, and patient obesity.
The Accuro device is designed to provide 3-D navigation to an anatomical target so a clinician may avoid guessing where the target is. The initial application of the Accuro device is for spinal anesthesia needle guidance.
“Because there are numerous clinical uses for Accuro, we believe it is a disruptive, game-changing device platform technology,” said John A. Williams, president and CEO. “The Accuro platform, which is based on automated 3-D 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.”
Spinal anesthesia often fails due to reliance on “blind” needle guidance. There are more than 20 million neuraxial anesthesia-related (epidurals and spinals) procedures per year in the United States. Twenty to 80 percent of all needle placement attempts fail, depending on operator skill, age, and patient obesity.