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www.fdanews.com/articles/205107-pediametrix-gets-fdas-510k-clearance-for-babys-head-measuring-app-softspot

PediaMetrix Gets FDA’s 510(k) Clearance for Baby’s Head Measuring App, SoftSpot

November 1, 2021

PediaMetrix has received the FDA’s 510(k) clearance for its SoftSpot mobile software application that helps clinicians measure and monitor infants’ heads.

The software is meant to replace the current method, in which pediatricians use a tape measure to determine the circumference of an infant’s head. The app enables pediatricians to use a smartphone to record a video of the infant, which the software uses to calculate the dimensions of the baby’s head and determine whether a baby has a condition that requires specialized care.

The Rockville, Md.-based company plans to introduce the app on the U.S. market before the end of the year.

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