OptiScan earns CE mark for automated bedside glucose, lactate monitoring system

The OptiScanner 6000 is a follow-up of the OptiScanner 5000 (pictured). It allows for the near continuous monitoring of blood lactate levels in addition to glucose levels. Image: OptiScan

OptiScan Medical picked up a CE mark for its automated bedside monitoring device for the intensive care unit. The company plans to launch the device, which tracks blood glucose and lactate near continuously, in the EU later this year.

The OptiScanner 6000, is the Hayward, California-based company’s follow-up to its OptiScanner 5000, a bedside glucose monitoring system for critically ill patients. The OptiScanner draws a small amount of blood—0.13mL per draw—every 15 minutes and separates out the plasma to be analyzed in an infrared spectrometer. A blood glucose reading is then displayed on the device’s screen. The OptiScanner 6000 offers simultaneous monitoring of lactate as well as blood glucose levels from a single blood sample, the company said.

Between 40% and 70% of ICU patients suffer from a temporary spike in blood glucose levels, while about 20% of ICU patients have pre-existing diabetes, necessitating strict glycemic control. Furthermore, as high lactate levels in critically ill patients are linked to adverse outcomes, the ability to monitor them on a near continuous basis could guide physician interventions and improve outcomes.

In addition to taking frequent blood glucose and lactate readings, the automated OptiScanner also cuts down on handling errors from manually drawn blood samples, OptiScan said.

"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," said OptiScan CEO Peter Rule in the statement. "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."

The device is not yet approved in the U.S., though the company announced in April 2014 that it had started enrolling participants in the pivotal U.S. study of its OptiScanner 5000.