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Medical Devices / Submissions and Approvals

FDA Clears Masimo Pulse Oximeter Device for Home Use

Jan. 12, 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.

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