Masimo (NSDQ:MASI) recently touted results from a study of its SpHb monitoring tech exploring its ability to detect possible anemia in patients undergoing spine or cytoreductive surgery, and said it won FDA 510(k) clearance for its Radius PPG tetherless sensor.
The Irvine, Calif.-based company said that results from its SpHb tech were published in the journal BMC Anesthesiology.
Researchers aimed to explore the ability of noninvasive and continuous hemoglobin monitoring with Masimo’s SpHb to help clinicians estimate when to conduct invasive hemoglobin measurements to detect possible anemia in patients undergoing spine or cytoreductive surgery.
Clinicians often forgo objective indications when making transfusion decisions during surgery, Masimo said, leading investigators to question whether non-invasive hemoglobin monitoring could aid in estimating when such measurements are appropriate.
A total 69 specifically selected patients scheduled for spine surgery or cytoreductive surgery were examined in the study, and were divided into a group who was monitored by the SpHb system and a group who received only the standard of care.
Study investigators said that they found the incidence of unnecessary hemoglobin measurement was lower in the SpHb group than the standard of care group. For a decrease of greater than 1 g/dL in lab hemoglobin, SpHb had a positive predictive value of 93.3% compared to only 54.5% for clinical perception, Masimo said. For patients with hemoglobin lower than 10 g/dL, PPV with SpHb was 86.7%, higher than the 50% for clinical perception.
“The SpHb trend tracked changes in hemoglobin satisfactorily during surgery and more accurately estimated the appropriate timing for invasive hemoglobin measurements than the clinicians. This study was the first diagnostic randomized controlled trial to explore the triage role of Pulse CO-Oximetry in the intraoperative detection of anemia. We found that the trend in SpHb could detect a decrease in Hb in dynamic situations and indicate the appropriate timing for further Hb measurements,” researchers wrote, according to a Masimo press release.
In a separate release, Masimo said that it won FDA 510(k) clearance for its Radius PPG tetherless sensor powered by its SET diagnostic which eliminates the need for a cabled connection to a pulse oximetry monitor.
With the device, patients can move freely and comfortably while still being continuously monitored, the company said. Measrurements are transmitted via a wireless connection and displayed on Masimo host devices or third-party multi-parameter monitors with integrated Masimo tech.
“We are excited to announce the Radius PPG tetherless, wearable SET pulse oximetry sensor solution. Accurate, high-quality monitoring data can now travel from an ambulating patient to a variety of monitoring platforms, allowing a patient’s physiological status to be continuously monitored when it’s needed most,” founder & CEO Joe Kiani said in a press release.
Earlier this month, Masimo saw shares fall despite the medical diagnostic maker posting first quarter 2019 earnings that topped expectations on Wall Street.