OptiScan Biomedical said today that its OptiScanner 5000 glucose monitoring system won 510(k) clearance.
The device is the first of its kind, providing physicians with trending and tracking information to manage their patients’ blood glucose levels in surgical intensive care units.
The Hayward, Calif.-based company’s technology uses alarms to alert clinicians when patients are experiencing hyperglycemia and hypoglycemia. The bedside system is automated, updating every 15 minutes with a new measure of glucose levels from plasma, as opposed to whole blood.
The FDA clearance was supported by results from OptiScan’s pivotal trial in 160 patients from surgical intensive care units comparing the accuracy of the company’s system to the industry standard glucose measurement in the ICU.
“This clearance by FDA is incredibly gratifying for the entire OptiScan team. We, along with many other companies in the medical device space, have dedicated considerable time and effort toward the goal of bringing continuous glucose monitoring technology into the ICU. We are proud to be the first company to have achieved success in the form of a regulatory clearance by FDA,” chairman & CEO Peter Rule said in prepared remarks.
“We believe the OptiScanner 5000 is well positioned to assist clinicians to improve the management of hyperglycemia and hypoglycemia in surgical intensive care unit patients.”
“As a clinician who has had the opportunity to work directly with the OptiScanner 5000 as part of its clinical studies, I am very pleased to know that I will now be able to implement the device broadly to enhance the care I am able to deliver to those patients for whom this FDA clearance applies,” Dr. Grant Bochicchio, chief of acute and critical care surgery at the Washington University School of Medicine, added.
“There is a broad consensus in the medical community regarding the need for automated, continuous and highly accurate glucose monitoring in the ICU and my experience with the OptiScanner 5000 indicates that this device will play a critical role in delivering this enhanced level of care. I look forward to implementing this technology as soon as possible.”
The OptiScanner 5000 also has CE Mark approval in the EU.