Jim Fidacaro’s Post

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SVP/GM | Global Commercialization and Operations Leadership | Board Advisor | Digital Health | Diagnostic Imaging | AI | Medical Devices | MBA

Owlet Baby Care is dedicated to providing an infant monitoring solution for every caregiver and baby. We have ensured equity-based requirements in every stage, including design and analysis for Owlet's recent FDA submissions. The Owlet BabySat and Dream Sock have undergone clinical evaluation for SpO2 accuracy in skin tone ranges from Type 1-VI on the Fitzpatrick scale. Our pulse oximetry devices' accuracy has been demonstrated on patients of all skin colors, and there is no clinically significant difference in accuracy or bias between darker skin and white skin tone infants. Owlet's commitment to data-driven decision-making aligns with our mission and the FDA's pursuit of accuracy and fairness in healthcare technology. https://lnkd.in/e_N6PwrB #OnlyOwlet #HealthcareInnovation #FDA #HealthTech #DataDrivenHealthcare #digitalhealth

FDA renews debate over biased pulse oximeters

FDA renews debate over biased pulse oximeters

axios.com

Alister Martin

CEO | A Healthier Democracy | Physician

7mo

This is fantastic news, Jim Fidacaro 👍🏽! Owlet's commitment to equity and accuracy in infant monitoring is commendable. It's reassuring to see advancements in healthcare technology that prioritize inclusivity and fairness.

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