OCT 06, 2025 08:30 EST
PediaMetrix received 510(k) clearance from the US Food and Drug Administration (FDA) for SoftSpotTM, a cross platform software solution for infant cranial evaluation at the point of care. The FDA clearance demonstrates SoftSpot’s safety and efficacy for infant cranial measurements using a smartphone.
“This is an important milestone for PediaMetrix and we see great potential in now bringing this innovative technology to pediatricians in the US and around the world”, said Fereshteh Aalamifar, PhD, President & CEO of PediaMetrix. Currently, pediatricians are not equipped with any tool for quantitative measurement of cranial shape and only perform visual assessment. They refer parents of children at risk to specialists for quantitative measurements, which can cause delays in the early detection and intervention. SoftSpot brings the power of a specialist to a pediatric office using a smartphone.