FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Masimo Gains CE Mark for Rad-97 Pulse CO-Oximeter and Connectivity Hub with Noninvasive Blood Pressure

March 21, 2017

Masimo has received CE marking of its noninvasive blood pressure (NIBP) measurements for the Rad-97 Pulse CO-Oximeter and connectivity hub.

The device provides a measure-through motion and low perfusion set pulse oximetry and upgradeable rainbow noninvasive blood constituent monitoring technology in a compact standalone monitor configuration which can also collect and remotely transmit data from connected devices.

The device enables clinicians to measure arterial blood pressure for adult, pediatric and neonatal patients, with three measurement modes: spot-check, automatic interval (which measures blood pressure routinely, at a desired interval) and stat interval (which continually measures blood pressure for a desired duration).

The device features a high-resolution, color display with multi-touch navigation and a rechargeable battery lasting seven hours. An optional roll stand allows for tether-less transport and an optional camera to allow clinicians and patients to communicate via video feed.

Rad-97 is not available in the United States. — Cynthia Jessup