Rivanna’s Accuro Device Secures Expanded Indication
Rivanna Medical has gained expanded FDA 510(k) marketing clearance for its Accuro product, a handheld, smart phone-sized ultrasound device that provides three-dimensional automated imaging guidance.
The device, previously indicated to guide spinal anesthesia, can be used for imaging in the abdominal, musculoskeletal, cardiac and peripheral vascular anatomies, the Charlottesville, Va., company said Monday. The product was approved in June.
President and CEO John A. Williams says the product can address a portion of an estimated $1 billion unmet market for imaging guidance. The company is in discussions with corporate partners for a U.S. market launch.
This is Rivanna’s first approved device. — Jason Scott