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SoftSpot™ is intended to be used for cranial measurement for infants from 1 month up to 2 years of age in conjunction with other clinical methods. SoftSpot™ is not intended to be used as a tool for preparing a helmet.

SoftSpot™ is a software that runs on a smartphone, tablet, PC, etc. and uses top view pictures of infant's head to measure cranial index (CI) and cranial vault asymmetry index (CVAI) similar to a mechanical caliper used by physicians which is also known as craniometer. After the photo is taken, the head contour is identified and then, based on the current standards of measuring infants' head shape, characterizing parameters including the ratio of width over length (known as Cranial Index or CI) and the ratio of difference in diagonals over the larger one (known as Cephalic Vault Asymmetry Index or CVAI) are calculated (see Test Principle below). The SoftSpot platform allows different users to upload or capture top view videos and photos of the infant's head. The user can be a physician/nurse (during well visits) or parents/guardians (between the visits). Once data are collected, they are sent to PediaMetrix Amazon Web Services (AWS) cloud. At PediaMetrix, the data analyst will use a windows-based software to download and analyze the data. The analysis includes conversion of the video into photos, standardization of the images (3x4, all nose up), selection of 5 good images, segmentation of the head contour and nose tip. Then, the software will calculate Cl and CVAI. Finally, a pdf report is generated with the results and sample top view photos and sent to the physician's account. Parents will also be notified when the results are ready. Then, the parent visits the physician (either in person or online) to discuss the results and next steps.