PediaMetrix

PediaMetrix, Inc. is a digital health company focused on developing artificial intelligence and computer vision solutions for pediatric care. The Rockville, Maryland-based firm was founded in January 2018 by the husband-and-wife team Dr. Fereshteh Aalamifar (CEO) and Dr. Reza Seifabadi (COO), alongside Dr. Marius G. Linguraru (CIO). The founders, alumni of institutions like Johns Hopkins University and the National Institutes of Health (NIH), were motivated by a personal experience with their own child to create more accessible diagnostic tools for pediatric conditions.

The company's flagship product is SoftSpot™, a mobile application that serves as a point-of-care tool for clinicians and parents to screen for and monitor infant cranial deformities. This includes conditions like deformational plagiocephaly (flat head syndrome), brachycephaly, and scaphocephaly. Traditionally, pediatricians relied on visual assessments and tape measures for head circumference, which could delay diagnosis and referral to specialists. SoftSpot streamlines this process by using a smartphone's camera to take a short video of the infant's head, from which its AI-powered algorithms calculate key cranial measurements, such as the Cranial Index (CI) and Cranial Vault Asymmetry Index (CVAI). The platform then generates a quantitative report for clinicians to interpret, facilitating early detection and intervention.

A significant milestone was achieved in October 2021, when PediaMetrix received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SoftSpot, making it the first smartphone app cleared for infant cranial measurements. This clearance covers the entire platform, including its mobile apps, AI backend, and cloud infrastructure. The company has secured funding through various channels, including a $1.93 million Fast-Track Small Business Award from the NIH's National Institute of Dental and Craniofacial Research (NIDCR) in 2022 to develop the next generation, SoftSpot3D. PediaMetrix has also received investments from TEDCO's Life Science Investment Fund and participated in several of its development programs. The business model appears to be prescription-based, with the app available to pediatric practices, enabling them to offer enhanced screening services.

Keywords: pediatric digital health, cranial measurement, plagiocephaly, flat head syndrome, SoftSpot app, FDA cleared medical device, computer vision, artificial intelligence in healthcare, infant health, telemedicine, pediatric diagnostics, craniosynostosis, brachycephaly, medical imaging, mobile health, point-of-care diagnostics, Fereshteh Aalamifar, Reza Seifabadi, pediatric technology, craniofacial abnormalities