Rivanna Medical has received U.S. FDA 510(k) clearance to market Accuro™, a handheld and untethered smart phone-sized device that is designed to guide a clinician using a needle or probe to a target within the human anatomy.
Background
There are 20+ million neuraxial anesthesia-related (epidurals and spinals) procedures per year in the US with estimates that between 20% to 80% of all needle placement attempts fail, due to reliance on “blind” needle guidance. Success depends on operator skill, age, and patient obesity, the latter two of which are a growing challenge.
It’s a ripe target then for the company that can offer a system to improve on the existing statistics.
Rivanna Medical’s Accuro™ product is the world’s first ultrasound system designed specifically for spinal anesthesia guidance. It is designed to provide 3D 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.
Company comments
“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 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 US market launch.”
Source: Business Wire
published: June 1, 2015 in: Approval/Clearance, Gynaecology/Obstetrics, Spine