OptiScan Biomedical said today it won CE Mark approval in the European Union for its OptiScanner 6000 intensive care unit monitor, which includes near-continuous glucose monitoring and serial monitoring of lactate levels.
The OptiScanner 6000 is an automated bedside monitor which uses a micro-sample of blood to track glucose and lactate, the San Francisco-based company said, aiming to prevent and combat hyper and hypoglycemia and sepsis.
“The receipt of the CE Mark for the OptiScanner 6000 is a key milestone for our company as it demonstrates the potential of our proprietary technology to function as a broad expanding platform capable of monitoring multiple analytes using a single micro-sample of blood. While near continuous monitoring of glucose in the ICU is critical, there are a number of additional metabolic analytes, including lactate, whose serial measurement is also important for optimizing patient care. By providing ICU physicians the means to serially monitor both lactate and glucose in the same, single micro-sample of the patient’s blood, we believe that the OptiScanner 6000 will play an important role in continuing to elevate the level of care delivered to ICU patients,” CEO Peter Rule said in a press release.
The company said recent sepsis definition changes suggest interventions for sepsis are considered more effective if lactate is shown to decrease over a given time period, making lactate level monitoring more important in the ICU.