Masimo wins CE Mark for RD Rainbow Lite SET sensors

Masimo (NSDQ:MASI) said today 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.
The Irvine, Calif.-based company said the rainbow Lite sensors use twice as many wavelengths of light as the company’s SET sensors, enabling ORi and RPVi monitoring along with SET measure-through motion and low perfusion pulse oximetry. ORi is designed to examine a patient’s oxygen reserve in the moderate hyperoxic range, the company said.
Masimo’s RPVi is a multi-wavelength version of the traditional Pleth variability index, and is designed to provide assessment of changes in fluid volume compared to PVi5.
“Rainbow Lite sensors allow clinicians, who depend on powerful SET pulse oximetry technology, to augment their patient monitoring with ORi and newly introduced RPVi. Given the positive reception of ORi in available markets, and feedback from clinicians who see great value in the benefits of ORi monitoring, we are excited to make ORi and RPVi accessible via the cost-effective solution represented by RD rainbow Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay only nominally more per sensor than for SET,” founder & CEO Joe Kiani said in a prepared statement.
With the new clearance, the company’s RD family of sensors are available in three levels of capability, including the RD Set, RD Rainbow Lite SET and RD Rainbow S...

Source: Mass Device - January 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Regulatory/Compliance Masimo Source Type: news