One of five FDA-funded grant programs focused on addressing these unmet needs, NCC-PDI is led by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s and the A. James Clark School of Engineering at the University of Maryland. Last year, NCC-PDI added new accelerators BioHealth Innovation and MedTech Innovator and design firm partner, Archimedic.
The finalists are receiving pitch coaching through BioHealth Innovation and are competing for a chance to receive awards up to $25,000 and participate in the newly created “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.
The 12 finalists are:
- 149 Medical Inc., Boston, Mass. – Near InfraRed Doppler Spectroscope (NIRDS) is a noninvasive, continuous monitor of blood flow in the neonatal brain, enabling early alerts and targeted therapy.
- AlgometRx, Inc., Washington, D.C. – The AlgometRx Rapid Drug Test is used to detect and monitor neonatal abstinence syndrome.
- Astarte Medical, Yardley, Pa. – NICUtrition are digital tools to support feeding, nutrition and gut health to improve outcomes for preterm infants.
- BrainTemp Inc., Bryn Mawr, Pa. – The BrainTemp System is a non-invasive device for continuous monitoring of brain temperature in neonates.
- Epitel, Salt Lake City, Utah – Epilog is a digital health company revolutionizing brain health monitoring.
- Lotus Ocean Biotech, LLC, Arlington, Mass. – The Smart Needle with Sound Guidance is a thin fiber optic sensor attached to the tip of a needle that can sense vessels and hear blood flow.
- Neoneur, Pennington, N.J. – Neoneur uniquely measures neonatal development through feeding, reducing risks, costs and readmissions.
- Novonate, South San Francisco, Calif. – LifeBubble secures and protects the umbilical catheter insertion site for neonates in intensive care.
- Prapela, Inc., Concord, Mass. – Prapela SVS is a reusable hospital bassinet pad that reduces apneic and oxygen desaturation events in preterm newborns.
- PyrAmes Inc., Cupertino, Calif. – Noninvasive and wireless, the Boppli Band allows for risk- and pain-free continuous blood pressure monitoring for neonates.
- Raydiant Oximetry, Mountain View, Calif. – Raydiant Oximetry Sensing Systems is a novel, non-invasive technology that more accurately detects fetal distress during labor and delivery.
- Rhaeos, Inc., Evanston, Ill. – FlowSense is a wearable device that enables noninvasive monitoring of ventricular shunt function in patients who have hydrocephalus.
“All of the companies that entered the competition are remarkable, but these finalists impressed us the most because of how their innovative medical devices solve a clinical challenge in the NICU and the feasibility of accelerating their commercialization process,” said Kolaleh Eskandanian, Ph.D., MBA, PMP, vice president and chief innovation officer at Children’s and principal investigator of NCC-PDI. “One in 10 babies is born prematurely, making NICU innovation an area where we can positively impact outcomes for a significant number of patients, so we want to support developers with funding, mentorship and regulatory guidance.”
The competition is one of many highlights that attendees can expect at the 7th Annual Pediatric Device Innovation Symposium, which co-locates with The MedTech Conference in Boston. The one-day, information-packed gathering of stakeholders from industry, government, academia and patient groups will begin with an opening keynote address from Melinda Richter, Global Head of Johnson & Johnson Innovation – JLABS, a network of life science incubators designed to foster new ideas to transform healthcare for all, including the very youngest of patients.
Richter will address the power of public and private collaboration. Next year, Johnson & Johnson Innovation and Children’s will launch JLABS @ Washington, DC at the new Children’s National Research & Innovation Campus. JLABS and Children’s will nurture and equip scientists and researchers to produce more novel solutions that currently do not exist for children. At the conclusion of Richter’s keynote, she’ll join a fireside chat with Eskandanian.
Keeping with the symposium’s tradition, Vasum Peiris, M.D., the chief medical officer for pediatrics and special populations at the FDA’s Center for Devices and Radiological Health, will deliver the closing address and provide an update on advancements and gaps in pediatric device innovation.
Three multidisciplinary panels will address the symposium theme “Pediatric Device Clinical Trials: Forging a Better Path” and a fourth panel will highlight the latest legislative activities of importance to the pediatric innovation community.
To register for the symposium, visit themedtechconference.com. For updates about speakers, panel themes and additional event details, visit pediatric-device-symposium.org.