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For Physicians


Clinical Validation

Owlet is being clinically validated for accuracy and sensitivity to critical events with Seattle Children’s Hospital. Owlet received the Institutional Review Board (IRB) approval. Preliminary accuracy test results show that Owlet is on par with pulse oximeters used in the medical field today. Additionally, hundreds of in-home tests demonstrated that Owlet’s simplified sensor placement design makes it easy for parents to achieve accurate sensor placement and higher fidelity measurements.

Making a Medical Device

The Owlet Smart Sock is not yet a medical device, but we are working on it. Owlet has developed collaborations with clinicians and researchers to create a device with medical applications. We were recently awarded a collaborator role on a $1.5 million grant from the National Institute of Health in the U.S. to further development and research. Owlet was also included in an exclusive two week program put on by the Mayo Clinic’s Center for Innovation in the U.S.

Simplified for Consumer Use

Owlet makes pulse oximetry simple and appropriate for everyday consumers. Traditional hospital pulse oximeters are infamous for their excessive false alarms and cause increased anxiety for caretakers. Our monitor uses an accelerometer to detect when the infant is moving to filter out corrupted data. As a result, Owlet has a much lower false alarm rate than traditional pulse oximeters. On average, parents see a false red alert once every few months.

Safe for Home Use

Traditional wired pulse oximeters pose several risks to infants including strangulation from the cord and burns. Owlet eliminates these risks with wireless operation; therefore, Owlet does not pose a strangulation risk to the infant. Owlet also uses lower power and intensity LEDS.


  • Has the Owlet Smart Sock been clinically tested?
  • The Owlet Smart Sock Sensor has been clinically validated for accuracy.
  • Is the Owlet Smart Sock FDA Approved?
  • The Owlet Smart Sock is not yet FDA cleared. We have submitted to the FDA for 510(k) clearance for a medical version of the product.
  • How do I learn more about the product?
  • You can learn more on our FAQ page.