Owlet, as the manufacturer of baby-monitoring ‘sock’, has made improvements and announced the approval of a new version of their alarm-sounding device, called BabySat, by the organization. BabySat, similar to its predecessor, the Smart Sock, is a stretchy, sensor-equipped sock that wraps around a baby’s foot.
It utilizes pulse oximetry technology to monitor heart rate and oxygen saturation levels in real-time. If either measurement deviates from predetermined limits, it promptly notifies a linked smartphone app.
Owlet had previously removed its Smart Sock for baby-monitoring from the market almost two years ago after receiving a warning letter from the FDA, which criticized its use as an unregulated gadget to notify parents about their children’s heart rates or blood oxygen levels exceeding healthy parameters. The FDA expressed concerns that the alerts could mislead parents into thinking their baby was experiencing desaturation and recommended a review of such devices. Owlet had already cautioned customers against using their monitoring system for diagnosis or treatment.
Unlike the Smart Sock, BabySat requires a doctor’s prescription for use. Doctors can establish the vital sign ranges that determine the device’s alerts, making it intended for infants requiring additional monitoring.
Kurt Workman, CEO of Owlet, believes that BabySat offers a transformative solution for parents who previously relied on restrictive conventional options. He sees it as advancing the betterment of hospital-grade technology for baby care.
Owlet Expands Baby-Monitoring Offerings with BabySat and Dream Sock Systems
- Owlet is set to launch the BabySat system in the US later this year, after obtaining FDA certification.
- Pricing details for BabySat have not been disclosed, but Owlet suggests potential insurance coverage, with reimbursement information expected soon.
- Owlet has submitted a de novo application for FDA clearance of its Dream Sock system, a baby monitor designed to track sleep quality indicators in healthy newborns.
- The current over-the-counter Dream Sock device, like the Smart Sock, utilizes pulse oximetry technology to monitor heart rate, oxygen levels, wake-ups, and movements.
Owlet aims to incorporate live displays of heart rate and oxygen saturation readings, as well as alerts for deviations from predetermined ranges, pending FDA clearance.
According to Owlet, the Dream Sock is currently not classified as a medical device and thus does not require FDA clearance. However, the company has submitted a de novo clearance request with the aim of incorporating live displays of heart rate and oxygen saturation readings in the system, along with alerts for when those vital signs deviate from predetermined ranges.
Also, read: Masimo launches baby monitor system Stork
