Masimo (NSDQ:MASI) said today it won FDA clearance clearing its Rad-97 pulse CO-Oximeter for home use.
The Irvine, Calif.-based company said the Rad-97 monitor features NomoLine capnography and noninvasive blood pressure monitoring technology from SunTech Medical, as well as its own continuous monitoring and SET pulse oximetry with upgradable rainbow tech.
The Rad-97 includes a multi-touch display, a small footprint and easy configuration, Masimo touted, with built-in enterprise WiFi and supported Bluetooth wireless connections to related compatible devices including thermometers, glucometers and weight scales.
The system also features an optional integrated camera to allow remote clinicians to interact with patients over live audio and video, the company said.
“Rad-97 is well-suited for a variety of care settings, now including home. Facilitated by its powerful connectivity and telehealth capabilities, Rad-97 allows clinicians to remotely interact with patients, as well as monitor their status and spot trends from afar through automated data collection and transfer,” Masimo founder & CEO Joe Kiani said in a prepared statement.
Last week, Masimo said it won CE Mark approval in the European Union for its RD Rainbow Lite SET sensors designed to monitor the company’s proprietary Masimo oxygen reserve index and RPVi.