PEDIAMETRIX
Rockville, Maryland (MD), United States
Healthcare
News
PediaMetrix gets FDA clearance for SoftSpot
The 510(k) clearance, which is designed for medical devices, covers all aspects of the platform: its fronted mobile apps and web platform, its backend AI and computer visions technology, and its AWS-based cloud platform.
“This is by far the biggest thing that can happen to a medical device/pharma company,” PediaMetrix CEO Dr. Fereshteh Aalamifar said. “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 means the company can move forward with bringing the technology to market in the U.S., and any other country that recognizes FDA clearance. The U.S. validation also eases the path to market in countries that have distinct regulatory clearance processes, including the European Union and Latin America. That’s important for PediaMetrix, as it is getting requests for the technology from English-speaking countries, Southeast Asia and Brazil.
Dr. Fereshteh Aalamifar. (Courtesy photo)
PediaMetrix was founded in 2018 by Aalamifar, who earned her Ph.D. at Baltimore’s Johns Hopkins University, and a group of scientists and entrepreneurs who are alumni of Johns Hopkins, Harvard University and Princeton University. It is designed to provide a tool for quantitative assessment of infants’ cranial conditions at the point of care. Currently, pediatricians use a tape measure for the measurement of head circumference only, and refer at-risk children to specialists, which can cause delays.
“Conditions with cranial deformity are on the rise and affect over 20% of newborns,” said Aalamifar, in a statement. “These conditions, including deformational plagiocephaly and brachycephaly and craniosynostosis, cause an estimated $1B cost to the US healthcare.”
Accessible for any smartphone, it allows pediatricians and parents to use the phone’s camera to take a short video, then uses image processing to make specific calculations about the head, and assists in the decision-making process for next steps. With data that demonstrated over 93% correlation with the standard cranial measurements used to determine whether patients have the conditions deformational plagiocephaly and brachycephaly, per the company, it is heading for a U.S. market launch in Q4 of 2021.
The approval will also lead to hiring. The company currently has 10 full-time and part-time team members in the U.S. and other countries. It is hiring in areas including data analysis, sales and marketing, and customer support. It will also seek quality assurance and reimbursement contractors in next few months, and is eyeing more R&D engineering hires in 2022.
Based out of the Rockville Innovation Center, PediaMetrix received investment from Maryland early-stage technology support agency TEDCO’s Builder Fund, as well as funding from the National Science Foundation through the Small Business Innovation Research program and Rockville-based BioHealth Innovation. It’s a graduate of accelerators including Reston, Virginia-based Startups Ignite and Annapolis, Maryland-based FounderTrac.
FDA clearance for software is evolving as tech develops, and PediaMetrix said its clearance is the first for a smartphone app category that’s specifically focused on cranial measurements. The approval comes around the same time as wider evolution of regulations at the Silver Spring-based government agency, as the FDA issued an action plan specifically geared toward AI and machine learning in software-as-medical device regulations in September.
“This is by far the biggest thing that can happen to a medical device/pharma company,” PediaMetrix CEO Dr. Fereshteh Aalamifar said. “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 means the company can move forward with bringing the technology to market in the U.S., and any other country that recognizes FDA clearance. The U.S. validation also eases the path to market in countries that have distinct regulatory clearance processes, including the European Union and Latin America. That’s important for PediaMetrix, as it is getting requests for the technology from English-speaking countries, Southeast Asia and Brazil.
Dr. Fereshteh Aalamifar. (Courtesy photo)
PediaMetrix was founded in 2018 by Aalamifar, who earned her Ph.D. at Baltimore’s Johns Hopkins University, and a group of scientists and entrepreneurs who are alumni of Johns Hopkins, Harvard University and Princeton University. It is designed to provide a tool for quantitative assessment of infants’ cranial conditions at the point of care. Currently, pediatricians use a tape measure for the measurement of head circumference only, and refer at-risk children to specialists, which can cause delays.
“Conditions with cranial deformity are on the rise and affect over 20% of newborns,” said Aalamifar, in a statement. “These conditions, including deformational plagiocephaly and brachycephaly and craniosynostosis, cause an estimated $1B cost to the US healthcare.”
Accessible for any smartphone, it allows pediatricians and parents to use the phone’s camera to take a short video, then uses image processing to make specific calculations about the head, and assists in the decision-making process for next steps. With data that demonstrated over 93% correlation with the standard cranial measurements used to determine whether patients have the conditions deformational plagiocephaly and brachycephaly, per the company, it is heading for a U.S. market launch in Q4 of 2021.
The approval will also lead to hiring. The company currently has 10 full-time and part-time team members in the U.S. and other countries. It is hiring in areas including data analysis, sales and marketing, and customer support. It will also seek quality assurance and reimbursement contractors in next few months, and is eyeing more R&D engineering hires in 2022.
Based out of the Rockville Innovation Center, PediaMetrix received investment from Maryland early-stage technology support agency TEDCO’s Builder Fund, as well as funding from the National Science Foundation through the Small Business Innovation Research program and Rockville-based BioHealth Innovation. It’s a graduate of accelerators including Reston, Virginia-based Startups Ignite and Annapolis, Maryland-based FounderTrac.
FDA clearance for software is evolving as tech develops, and PediaMetrix said its clearance is the first for a smartphone app category that’s specifically focused on cranial measurements. The approval comes around the same time as wider evolution of regulations at the Silver Spring-based government agency, as the FDA issued an action plan specifically geared toward AI and machine learning in software-as-medical device regulations in September.
11 Jan 2023
PediaMetrix Recevies $1.93M
PediaMetrix, Inc., the creator of SoftSpotTM, the only FDA-cleared mobile app for cranial evaluation at the point of care, received official notification from the National Institutes of Dental and Craniofacial Research (NIDCR) that it has been awarded a $1.93 million Fast-Track Small Business Award over a 2.5-year period to further develop SoftSpot for comprehensive evaluation of cranial shape abnormalities, including Deformational Plagiocephaly and Craniosynostosis.
The funding will be disbursed in two phases contingent meeting milestones, with Phase I of it ($252,000) being available effective immediately.
The National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Fast Track Program was created to provide grants to accelerate the transition from development stage to commercialization of innovative technologies that improve human health and advance the mission of the NIH. The program also aims to foster partnerships among a variety of R&D collaborators working toward these goals. To this end, PediaMetrix has partnered for this project with the Children’s National Hospital’s in Washington DC.
"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" said Dr. Fereshteh Aalamifar-founder and Chief Executive Officer and the PI of this grant.
Reza Seifabadi, Ph.D., PediaMetrix's co-founder, COO and co-principal investigator on the project, commented, "we are grateful to NIDCR of this recognition and award- 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".
PediaMetrix has experience in using federal funding support to translate computer vision and AI products into the clinic through substantial grants from the National Science Foundation’s SBIR program and from the Maryland’s TEDCO Builder Fund and Seed Fund programs.
PediaMetrix has launched SoftSpot in the US market after receiving FDA clearance in October 2021. SoftSpot has been used in many practices in the US to successfully evaluate hundreds of patients.
Current version of SoftSpot uses computer vision and AI to provide pediatricians and parents with a tool for early detection and monitoring of Deformational Plagiocephaly, Brachycephaly and Schaphocephaly. These common conditions affect nearly 30% of newborns with an estimated $1B costs to the US healthcare. Currently, pediatricians do not have access to any tool for measurements of head shape deformities and delayed diagnosis has resulted in expensive and intensive treatment options.
PediaMetrix’s mission is to provide AI and computer vision solutions to critical pediatric needs with lower healthcare costs and improve outcomes. PediaMetrix’s lead product, SoftSpot, enables early detection and management of the most common conditions with head shape abnormalities in newborns. Founded by alumni entrepreneurs and scientists from Johns Hopkins, Oxford, and NIH, PediaMetrix currently has 17 full-time, part-time employees and contractors and is expanding its R&D and sales and marketing team. For more information, visit http://www.PediaMetrix.com.
The funding will be disbursed in two phases contingent meeting milestones, with Phase I of it ($252,000) being available effective immediately.
The National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Fast Track Program was created to provide grants to accelerate the transition from development stage to commercialization of innovative technologies that improve human health and advance the mission of the NIH. The program also aims to foster partnerships among a variety of R&D collaborators working toward these goals. To this end, PediaMetrix has partnered for this project with the Children’s National Hospital’s in Washington DC.
"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" said Dr. Fereshteh Aalamifar-founder and Chief Executive Officer and the PI of this grant.
Reza Seifabadi, Ph.D., PediaMetrix's co-founder, COO and co-principal investigator on the project, commented, "we are grateful to NIDCR of this recognition and award- 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".
PediaMetrix has experience in using federal funding support to translate computer vision and AI products into the clinic through substantial grants from the National Science Foundation’s SBIR program and from the Maryland’s TEDCO Builder Fund and Seed Fund programs.
PediaMetrix has launched SoftSpot in the US market after receiving FDA clearance in October 2021. SoftSpot has been used in many practices in the US to successfully evaluate hundreds of patients.
Current version of SoftSpot uses computer vision and AI to provide pediatricians and parents with a tool for early detection and monitoring of Deformational Plagiocephaly, Brachycephaly and Schaphocephaly. These common conditions affect nearly 30% of newborns with an estimated $1B costs to the US healthcare. Currently, pediatricians do not have access to any tool for measurements of head shape deformities and delayed diagnosis has resulted in expensive and intensive treatment options.
PediaMetrix’s mission is to provide AI and computer vision solutions to critical pediatric needs with lower healthcare costs and improve outcomes. PediaMetrix’s lead product, SoftSpot, enables early detection and management of the most common conditions with head shape abnormalities in newborns. Founded by alumni entrepreneurs and scientists from Johns Hopkins, Oxford, and NIH, PediaMetrix currently has 17 full-time, part-time employees and contractors and is expanding its R&D and sales and marketing team. For more information, visit http://www.PediaMetrix.com.
11 Jan 2023
About
Our mission is to bring smart digital health solutions to pediatric care. We have the vision to revolutionize pediatric health by giving parents as well as pediatricians access to accurate and reliable diagnostic tools at the point-of-care through data-driven machine learning and image processing methods. Our startup has started with one of the most common conditions in newborns, i.e. positional plagiocephaly or flat head syndrome. Our flat head syndrome app enables parents to receive accurate measures of their baby's head shape and receive repositioning instructions specific to their baby instantaneously. Pediatricians will also have access to the data and the easy-to-understand analysis of the smart algorithms behind the app to save time while ensuring quality care.
