RIVANNA's Ultrasound Platform and AI Software Gain FDA Clearance

Jul 19, 2025
RIVANNA has received FDA 510(k) clearance for its Accuro 3S ultrasound system and SpineNav-AI software, enabling their use in U.S. hospitals for enhanced needle and catheter placement.

RIVANNA has received 510(k) clearance from the U.S. Food and Drug Administration for its Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software, announced in a press release. This clearance allows these technologies to be used in U.S. hospital and clinical settings to provide anatomical guidance during needle or catheter placement.

The Accuro 3S is a portable, point-of-care ultrasound system featuring a Dual-Array convex probe and integrated SpineNav-AI software. This system supports standard B-mode imaging and includes a touchscreen interface and healthcare IT connectivity for DICOM-based workflows. The SpineNav-AI software uses machine learning to assist in musculoskeletal imaging assessments, offering automated landmark detection and identification of critical spinal anatomy.

RIVANNA plans to pursue additional regulatory submissions for further capabilities of the Accuro 3S and is preparing for a limited release to select academic medical centers, followed by a broader market launch.

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