Masimo wins FDA 510(k) for Rad-67 pulse co-oximeter

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-67 pulse co-oximeter system.

The Rad-67 offers both Rainbow non-invasive hemoglobin measurement and measure-through motion and low perfusion SET pulse oximetry, and can be used with the Irvine, Calif.-based company’s Rainbow DCI-mini sensor for spot-check monitoring.

The system also features a rechargeable battery with a six-hour run time and a high-resolution color display with touchscreen navigation.

Masimo said that the combination of spot-check monitoring measurements of both oxygen saturation and non-invasive hemoglobin makes it viable as a single-device solution in clinical and non-clinical settings.

“The Rad-67 is incredibly easy to use and gives a quick result, perfect in our busy pre-operative clinic. We have found it particularly useful as it helps us target those patients who may need further testing,” Dr. Andrew Klein of Cambridge, U.K.’s Royal Papworth Hospital said in a press release.

The company clarified that the Rad-67 spot-check SpHb monitoring is not cleared for pediatric patients, pregnant patients or patients with renal disease, and that it is not intended to replace laboratory blood testing.

“We’re proud to launch Rad-67, Spot-check next generation SpHb monitoring, and the rainbow DCI-mini in the United States. Spot-check Next Generation SpHb monitoring represents a significant enhancement to the noninvasive measurement we invented a decade ago – a measurement we look forward to continuing to improve,” founder & CEO Joe Kiani said in a prepared statement.

Earlier this month, Masimo said that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients.

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