RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software
Shots:
- Accuro 3S ultrasound system & SpineNav-AI received FDA clearance to provide anatomical guidance during needle or catheter placement; further regulatory filings for advanced features are planned, alongside ongoing clinical collaborations, limited release, & upcoming full market launch
- Accuro 3S is a portable system featuring SpineNav-AI & a Dual-Array convex probe with 2 aligned transducer arrays separated by a narrow gap, allowing in-line needle access via probe’s center to form combined images for improved visualization
- SpineNav-AI is an ML-based software that supports real-time lumbar spine imaging during anesthesia by automatically detecting key spinal landmarks, indicating spine midline, depth to epidural space & its position
Ref: Prnewswire | Image: RIVANNA | Press Release
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