SoftSpot3D: prospective study of mobile 3D reconstruction for infants' cranial conditions.

Purpose: Deformational plagiocephaly and craniosynostosis require early detection for effective and less invasive interventions. Although 3D imaging and automated analysis allow for image-based assessment by nonspecialists, current 3D imaging systems are often costly and immobile. We present SoftSpot3D, a mobile three-dimensional head reconstruction framework designed as an accessible, low-cost screening solution for infant cranial assessment. Approach: The system is independent of marker placement, leveraging a patterned cap strictly for feature-based tracking rather than geometric registration. Developed for iPad using consumer-grade RGB-D sensors, our pipeline mitigates infant motion through RGB-D odometry and generalized iterative closest point refinement to generate accurate cranial models. Clinical metrics are then automatically extracted by analyzing cross-sectional contours at the standardized measurement plane. Results: Validated against the 3dMD (3dMD LLC, Atlanta, Georgia, United States) medical-grade stereophotogrammetry system on 143 infants (mean age: Conclusion: These results establish the clinical accuracy of the system as an accessible, low-cost screening solution, providing the evidence base for its integration into routine pediatric care to enable more efficient early detection and referrals. Furthermore, the framework automatically generates a structured clinical report incorporating quantitative metrics and multiview visualizations, facilitating immediate point-of-care decision-making.