SpineUs™ System

The SpineUs System is an innovative, software-based, tracked ultrasound imaging solution designed for diagnostic musculoskeletal applications of the spinal region, enabling precise measurement of anatomical components like intervertebral angles and spine curvature. This device integrates artificial intelligence for vertebral bone tissue segmentation and an optical tracking system, proving its safety and effectiveness through comprehensive testing and demonstrating substantial equivalence to predicate devices.

Verdure Imaging's SpineUs System is a software-based, tracked ultrasound imaging system designed for diagnostic musculoskeletal applications, specifically targeting the spinal region. Intended for use by trained chiropractors and radiologists in hospital or medical clinic settings, the system assists in acquiring, viewing, and measuring ultrasound images of the spine. It enables the measurement of spine-related anatomical components, such as intervertebral angles and spine curvature, and supports the review and management of patient measurement data as an adjunct to conventional imaging methods. The system integrates a cleared ultrasound scanner, a consumer PC running the dedicated SpineUs application, and an optical tracking system, leveraging artificial intelligence for vertebral bone tissue segmentation. A review of the SpineUs System concluded that it is substantially equivalent to a legally marketed predicate device regarding its safety and effectiveness. This determination was based on the device's fundamental scientific technology, technological characteristics, intended use, environment of use, and stated indications for use. Comprehensive non-clinical and clinical performance testing was conducted to verify the device's safety and performance, including evaluation of its AI segmentation capabilities and the accuracy of its measurements when compared to conventional imaging, ensuring compliance with applicable safety standards.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the SpineUs System's AI segmentation accuracy for vertebral bone tissue compare to established imaging modalities across different spinal pathologies?; What is the demonstrated clinical utility and added value of using SpineUs measurements (e.g., intervertebral angles, spine curvature) as an adjunct to conventional imaging in specific patient cohorts?; What are the specific performance metrics for the optical tracking system regarding its precision, stability, and robustness in different clinical environments or patient positions?; Does the substantial equivalence determination imply comparable diagnostic performance across all indications where conventional imaging is currently used, or are there specific limitations?; Are there ongoing or planned studies to evaluate the long-term clinical outcomes or impact on patient management resulting from the use of the SpineUs System in chiropractors' and radiologists' practices?