www.fdanews.com/articles/185177-fda-clears-masimo-pulse-oximeter-device-for-home-use
FDA Clears Masimo Pulse Oximeter Device for Home Use
January 11, 2018
The FDA cleared Masimo’s Rad-97 Pulse CO-Oximeter device for home use.
The Rad-97 uses a “compact, standalone monitor that combines advanced connectivity and communication capabilities for telehealth with an interface easily customized for used at home,” the company said.
The device captures patient data in real-time from third-party Bluetooth-enabled devices, such as thermometers and weight scales. It can also include an optional integrated camera for clinicians to remotely interact with patients via live video and audio.