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SoftSpot, the Only FDA-Cleared Mobile App for Infant Cranial Measurement at the Point of Care

What is SoftSpot?

SoftSpot, developed by PediaMetrix, is the first and only FDA-cleared mobile app for cranial measurement and evaluation at the point of care. It enables the early detection and management of common conditions with head shape abnormalities in newborns, including plagiocephaly, brachycephaly and craniosynostosis.

The Current Landscape

Currently, pediatricians - who are at the front line - do not have access to any tool to measure head shape parameters and only perform visual assessment. If concerned, they refer parents to specialists where they use certain tools such as a craniometer or a 3D scanner. This can cause delay in diagnosis leading to expensive and intensive treatment options such as helmet therapy (for non-synostotic head deformities) or open surgery vs. minimally invasive surgery (for synostotic cases). SoftSpot brings the power of a specialist to the point of care, i.e., at home or in a pediatric office using a smartphone, thus enabling early detection and intervention. It also helps with early and objective referral to a specialist when necessary.

Company Birth Story

PediaMetrix, Inc. is founded by husband-and-wife duo, Freya (Fereshteh) Aalamifar, PhD, and Reza Seifabadi, PhD based on a personal experience with their child. Fereshteh, also the CEO, got her PhD from Johns Hopkins University and has work experience at the Children’s Hospital and National Institutes of Health. She has a passion for bringing technology to childcare and founded PediaMetrix out of her love of being a mother to two little boys.

Reza, the COO of PediaMetrix, has an extensive background in the medical device field and 10 years of work experience at the National Institutes of Health, Johns Hopkins, and Children’s Hospital of Washington, D.C. He is an entrepreneur in the medical device industry and is the inventor of seven U.S. patents.

Together, their company developed SoftSpot, the only FDA-cleared mobile app for measuring infants' cranial deformities, which can assist pediatricians and parents with early detection, monitoring, and treatment of head deformity conditions. Hundreds of infants have been scanned using SoftSpot and currently 20 US pediatric practices are using it. Fereshteh and Reza believe that SoftSpot can improve patient outcomes, decrease patient costs in the long-term, and increase revenue for providers.

The Solution

Currently, SoftSpot2D is available in the US market serving patients with deformational plagiocephaly and brachycephaly (DPB). DPB is the most common cranial deformity condition affecting 20-30% of newborns in the US. PediaMetrix partners with some of the major distribution channels and partners to bring SoftSpot to patients. PediaMetrix is also working to bring SoftSpot to the international market by working with overseas medical device distributors and regulatory advisors and exhibiting at tradeshows. In addition, PediaMetrix is developing the next generation of the product called SoftSpot3D which enables a comprehensive evaluation of the head for nearly all conditions including craniosynostosis. Until now, there has not been a tool available to the point-of-care for 3D scan of the head in an economic and user friendly way. PediaMetrix is going to democratize the access to 3D scan of the head shape using a smartphone and provide a decision support tool for clinicians and providers using AI solutions.

A Customer Story

"SoftSpot is changing the way we diagnose and treat plagiocephaly. Now, we can take serial measurements and monitor the progression of the baby’s cranium and intervene early. The process is time efficient, and it generates revenue for the practice." -Dr. Susan Sirota, MD, FAAP, an early adopter of SoftSpot

A Founder Quote

Speaking on a recent $1.93 million award from the National Institutes of Dental and Craniofacial Research (NIDCR), founder and Chief Executive Officer of PediaMetrix, Dr. Fereshteh Aalamifar said, “With this award, the NIDCR recognizes PediaMetrix team’s ability to bring a comprehensive mobile scanning tool to pediatric offices that can offer 3D scan of a patient’s head in a short time, provide precise measurements for different cranial indices, as well as decision support information for diagnosis of different conditions"

Co-founder and Chief Operating Officer, Reza Seifabadi continues, “This will bring SoftSpot to a whole new level allowing pediatricians to evaluate virtually any cranial abnormalities, including craniosynostosis – a condition often requiring surgery, with high precision. Early detection will facilitate early intervention, which ultimately provides better outcome and reduce healthcare costs"

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