Compact-ultrasound developer SonoSite has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Edge ultrasound scanner.
Edge is designed for clinical assessment and procedural guidance at a hospital bedside and in a physician's office. The system features new imaging algorithms to enhance visualization of images and allow clinicians to reach deeper levels of penetration, the company said.
Edge also offers a high-luminance LED high-resolution 12-inch display for enhanced viewing of procedures across a patient's bed. It is available with 14 transducers to support examinations and procedures including thoracic assessment for pathology, vascular access, and needle aspirations and injections, as well as abdominal, cardiac, ob/gyn, musculoskeletal, small parts, and vascular scanning.
SonoSite now plans to begin shipments in the U.S. International deliveries are pending CE Mark approval.
