Company: Owlet
Co-Founder & CEO: Kurt Workman
Website: https://owletcare.com/
About Owlet
Owlet is the only company to offer FDA-cleared and medically certified wearable pediatric monitors, bringing hospital-grade health technology directly into the home. Built on the largest real-world pediatric health dataset, the platform turns biometric data from more than 2.5 million monitored babies into insights for parents and clinicians.
The company was founded in 2012, when Kurt Workman, a chemical engineering student at Brigham Young University, watched his aunt give birth to premature twins and shoulder relentless round-the-clock worry. The moment was personal: his wife had a congenital heart defect, and his cousin had already lost a baby to Sudden Unexpected Infant Death, one of more than 3,000 such deaths that occur in the U.S. every year.
A classmate introduced Kurt to pulse oximetry, the hospital technology used to measure heart rate and oxygen saturation, and he wondered why that same technology was not available to parents at home. Alongside fellow BYU classmates, Kurt built the Smart Sock, a wearable monitor for newborns that alerts parents when heart rate or oxygen levels move outside safe ranges. It launched commercially in 2015, and a peer reviewed study later found the device flagged 47 clinically verified life threatening cases.
As the baby monitor category grew crowded with competitors making unverified claims about tracking infant vitals, Owlet chose a harder path: pursuing formal FDA clearance, which was a rigorous, multi-year process. In 2023, Owlet became the first and only company to receive FDA De Novo clearance for an over the counter infant wearable, later adding a second clearance for BabySat, a prescription pulse oximeter for infants needing clinical grade monitoring at home.
That regulatory rigor became the foundation for a shift in how infant health is delivered. In September 2025, the FDA issued a formal safety communication warning families against unregulated monitors making unauthorised health claims, drawing a clear line between Owlet devices and every uncertified product in the category, and validating the years Owlet spent building clinical credibility.
Owlet has used that credibility to move infant monitoring out of the nursery and into the broader healthcare system. BabySat now integrates directly into electronic health record and remote patient monitoring workflows, giving pediatric clinicians ongoing visibility into infant vitals after a baby transitions home from the ICU. Expanded insurance and Medicaid coverage has brought that same clinical grade monitoring to families who would otherwise have no access to it.
Underpinning all of it is a dataset built from more than 21 trillion heartbeats, one of the largest real world pediatric health datasets in existence, which Owlet is using to move the category away from passive observation and toward a preventive model of infant care.
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