# Mobile Three-Dimensional Screening for Cranial Malformations

> **NIH NIH R44** · PEDIAMETRIX INC. · 2024 · $44,553

## Abstract

ABSTRACT
 Delayed identification of infant head malformation is causing unnecessary medical complications and societal
costs. A critical challenge in the early detection is the absence of tools available to pediatric offices to perform
quantitative head shape assessment during well-child visits. Delays in diagnosis limit the opportunity for early,
less invasive and effective treatment options. In this Fast-track SBIR project, PediaMetrix Inc. has joined forces
with pediatric hospitals and providers to develop and evaluate SoftSpotTM, which is the first mobile digital tool for
3D data collection and analysis of infant cranial malformations at the point-of-care.
 Head malformations during infancy can be synostotic (i.e., craniosynostosis) or nonsynostotic (such as
deformational plagiocephaly and brachycephaly or DPB). Both types of conditions require immediate attention
and benefit from early treatment to avoid long-term health complications. The prevalence of DPB increased
dramatically in recent years, from 5% to approximately 20%-30%, causing the condition to be called a pediatric
epidemic. Craniosynostosis is less common affecting 1 in 2,000 children. To improve the early management of
these conditions and to prevent more complex treatment and associated morbidities, it is essential to monitor
the growth of the infant head at the point-of-care.
 To address this unmet clinical need, we will develop and evaluate a mobile digital tool that will enable
pediatricians to capture and analyze 3D scans of every infant for the early diagnosis and management of cranial
malformations. In the Phase I of this project, we will develop a novel technology to rapidly capture and analyze
3D data of the top of cranium in just seconds. We will use machine learning methods to automatically compute
the head shape parameters, including the head circumference which is routinely performed during every child
visit, but currently with an outdated and unreliable measuring tape. Our technology will be designed for the
general cranial evaluation of all infants during well-child visits. In Phase II, we will develop methods for the 3D
reconstruction and analysis of the full cranium from a smartphone. We will also train deep learning models to
classify types of craniosynostosis and other cranial conditions and conduct clinical evaluation and user-feasibility
studies.
 The overall mission of PediaMetrix is to provide accurate decision support tools for pediatric health at the
point-of-care. This will be achieved through machine learning and quantitative imaging algorithms that in
combination with smartphone technological advances will be packaged as mobile digital health solutions
accessible to pediatric health providers at any time and location. Successful demonstration of SoftSpot3DTM will
lead to a significant reduction of the number of children left with untreated cranial conditions in addition to
lowering the associated healthcare costs and social anxiety.

## Key facts

- **NIH application ID:** 11040436
- **Project number:** 3R44DE031461-03S1
- **Recipient organization:** PEDIAMETRIX INC.
- **Principal Investigator:** Fereshteh Aalamifar
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $44,553
- **Award type:** 3
- **Project period:** 2023-09-01 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11040436

## Citation

> US National Institutes of Health, RePORTER application 11040436, Mobile Three-Dimensional Screening for Cranial Malformations (3R44DE031461-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11040436. Licensed CC0.

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