Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its Eve critical congenital heart disease newborn screening application which runs on the company’s Rad-97 and Radical-7 pulse co-oximeters.
The Eve application is designed to streamline CCHD screenings by providing visual instructions, animations and automatic synchronization algorithms with a detailed display of screening results, the Irvine, Calif.-based company said.
Eve also enables the incorporation of perfusion index measurements into screening, which Masimo said has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion rates.
“Multiple studies have shown that Masimo SET pulse oximetry can help improve CCHD screening, helping to save many newborns’ lives while reducing the cost of care. Eve builds on the powerful benefits of SET by transforming pulse oximeters into intuitive screening tools which can help clinicians perform the crucial work of screening newborns in an easy-to-follow and intuitive application,” CEO Joe Kiani said in press release.
Last month Masimo released results from a study of its Oxygen Reserve Index’s ability to function as an early warning of impending arterial hemoglobin desaturation in obese patients, touting its ability to provide advanced warning in the high risk patient population.