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About

smallTalk® is a seed-stage medical device startup focused on supporting and improving brain development in preterm infants. Our first product, the NICU Egg, is the only speaker system designed specifically to deliver recorded family voices safely and effectively to infants in NICU care. Nearly 400,000 U.S. infants are hospitalized in NICUs each year, where separation from family and a lack of "infant-directed speech" — critical for early brain development — can contribute to poor neurodevelopmental outcomes. In the United States, fewer than 20% of parents are able to visit the NICU daily, making in-person interaction insufficient. The NICU Egg addresses this gap. It automatically adjusts playback volume and duration for safety, features a sealed design that meets infection control standards, and is simple to use for both families and NICU staff. Our parent app (for recording voice) and hospital app (to manage recordings) operate on a secure, HIPAA-compliant platform. Now available, the NICU Egg is being adopted in top NICUs nationwide. We haven't stopped there. With support from a $2.5M NIH grant, we're developing our second product: the Active Egg System. This system pairs the NICU Egg speaker with the Paci™ sensor, a reusable device that fits into a standard NICU pacifier, sending real-time suck strength data to the Egg. This technology enables the Egg to deliver recorded voice contingent upon the action of the infant; an active learning system. In published clinical studies, this concept has demonstrated exciting results in brain development biomarkers. The Active Egg is currently in an NIH sponsored pivotal clinical trial and will launch following FDA clearance.

Technologies
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Keywords
pediatric devices neonatology medical devices consumer products infant care preterm infants neurodevelopment neonatal intensive care neonatal therapy nicu medical equipment manufacturing infection control medical device nicu egg speaker developmental care healthtech b2b infant bonding parent app child development volume control algorithms sound therapy government services early language exposure neural pathways family connection medical equipment and supplies manufacturing healthcare nicu support
Company Information
  • Employees 7
  • Founded 2018
Location

Cleveland, Ohio, United States, 44101

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