Medical technology company Rivanna Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Accuro platform.
Accuro is a handheld and untethered smart phone-sized device, which has been designed to guide a clinician using a needle or probe to a target within the human anatomy.
The device is said to provide 3D navigation to an anatomical target, helping clinician to avoid guessing. Its initial application is for spinal anesthesia needle guidance.
Rivanna Medical president and CEO John Williams 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 US market today."
Rivanna said that Accura is also 510(k) cleared for a variety of additional imaging applications such as diagnostic imaging of the cardiac and abdominal anatomies and is the world’s first ultrasound system designed specifically for spinal anesthesia guidance.