PediaMetrix’s SoftSpot App Receives FDA Approval for Cranial Measurement

SoftSpot is the first mobile app to receive FDA approval for these measurements.

Written by Charli Renken
Published on Oct. 26, 2021
PediaMetrix’s SoftSpot App Receives FDA Approval for Cranial Measurement
PediaMetrix fda approval
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Rockville-based healthtech startup PediaMetrix recently announced its SoftSpot app received 510(k) clearance from the U.S. Food and Drug Administration. SoftSpot is the first mobile app to receive approval from the FDA for cranial measurement, according to a company announcement earlier this month. 

The mobile app allows clinicians and parents to measure and monitor infants’ heads with AI and computer visions technology. These cranial measurements are important for tracking an infant’s growth and development, particularly when it comes to babies with cranial deformities.

Cranial deformities have been on the rise since the 1990s, possibly as a result of more babies being put to bed on their backs to prevent Sudden Infant Death Syndrome. While this practice is recommended by the American Academy of Pediatrics, in some cases, it can lead to plagiocephaly or “flat head syndrome.” Not enough tummy time isn’t to blame for all cranial deformities, though. Some babies are also born with defects that require regular head measurements and monitoring.

Typically, a doctor will take measurements of an infant’s head with a tape measure and refer at-risk patients to a specialist. Engineer and mom Fereshteh Aalamifar wanted a better, faster solution for measuring and monitoring infants’ cranial development. So, she founded PediaMetrix in 2018 to design a tool for parents to easily measure their infant’s head at home and upload that information for pediatrician review. That’s where the SoftSpot app comes in. 

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With SoftSpot, pediatricians and patients can simply use their smartphone to take a short video of an infant’s head and receive specific calculations through image processing technology. These measurements provide quantitative data that can help pediatricians make decisions about patient care.

Now that the FDA has approved PediaMetrix’s technology, the company can bring its app to the U.S. market as well as other countries that recognize FDA clearance. This means more pediatricians will be able to quickly and efficiently monitor cranial deformities and hopefully intervene sooner rather than later. 

It also means PediaMetrix can hire more team members, expanding from their current team of 10. According to Technical.ly DC., the company is currently hiring for data analysis, sales, marketing and customer support, with more positions opening in other areas soon. 

“This is by far the biggest thing that can happen to a medical device/pharma company,” Aalamifar told Technical.ly. “FDA approval is a badge of honor showing you have satisfied a rigorous review process by the FDA, showing your device is safe and effective for the intended use.”

It’s been a big year for PediaMetrix. The startup also raised a seed round led by TEDCO in September.

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