Tag: pulse oximetry

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Latest EnsoData FDA Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices

EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high-quality, accessible, and cost-effective approach to diagnosing sleep […]

Owlet Infant Pulse Oximetry Sock Gets FDA Clearance
Technology

Owlet Infant Pulse Oximetry Sock Gets FDA Clearance

Owlet announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and with BabySat, combines its consumer-first expertise with hospital-grade monitoring accuracy. “Our […]

masimo no racial bias
Technology

Masimo SET Pulse Oximetry, No Racial Bias Found

Masimo announced the findings of an abstract presented at the Society for Technology in Anesthesia 2022 Annual Meeting, which reviewed retrospective pulse oximetry data and concluded that there was no clinically significant bias based on ethnicity for black and white volunteer subjects monitored with Masimo SET® pulse oximetry and RD […]

masiomo dual set
Product News

Masimo Launches Dual SET Pulse Oximetry

Masimo has announced Dual SET® Pulse Oximetry for Root®, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET® Oximetry is a significant advancement to Masimo SET®-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET® MOC-9® module and the addition of […]