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FDA grants clearance for CGM in the surgical ICU

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The FDA granted clearance to OptiScan Biomedical Corporation for its OptiScanner 5000 Glucose Monitoring System, which will allow use of the system for monitoring plasma glucose levels and determining dysglycemia in patients in surgical ICUs, according to a press release.

“This clearance by FDA is incredibly gratifying for the entire OptiSan team,” Peter Rule, chairman and chief executive officer of OptiScan Biomedical, said in the release. “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 believe the OptiScanner 5000 is well positioned to assist clinicians to improve the management of hyperglycemia and hypoglycemia in surgical intensive care unit patients.”

The OptiScanner 5000 is an automated, bedside CGM system that will provide hospital providers with information to correctly manage patient glucose levels in the ICU.

The clearance is based on results from a multicenter clinical trial that included 160 patients in a surgical ICU to compare efficacy of the OptiScanner 5000 to industry standard glucose measurement in the ICU; the study revealed OptiScanner 5000 to be safe and effective.

“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,” Grant V. Bochicchio, MD, MPH, FACS, chief of acute and critical care surgery, Harry Edison Professor of Surgery at Washington University School of Medicine, said in the release. “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.”