Proceeds to Support U.S. Commercialization of OptiScanner 5000 and Ongoing Platform Expansion [...]
Automated Bedside Monitoring for Critical Care
Glucose monitoring now cleared by the FDA
Providing clinicians with valuable trending data to support early detection of changes
OptiScan Biomedical’s lead product, the OptiScanner® 5000, is a first-of-its-kind bedside blood monitoring platform that provides plasma-based, automated monitoring of patients’ glucose levels without the need for calibration. OptiScan Biomedical is expanding the OptiScanner platform to include additional metabolic and hemodynamic analytes using the same sample of blood. Learn more
Designed to Monitor What Matters
Achieving Glucose Control
Critically ill patients frequently suffer from stress-induced hyperglycemia, glycemic variability or hypoglycemia which has been associated with increased morbidity and mortality in both diabetic and non-diabetic patients.
The OptiScanner 5000, which directly measures plasma glucose levels using an integrated blood centrifuge and spectrometer, delivers automated monitoring, the convenience of no calibration and insights into trending data with the goal of avoiding dangerous glycemic variations and achieving the right level of glucose control. Learn More
The OptiScanner 6000 represents the first step of platform expansion, with the goal of providing hospitals and healthcare practitioners with a single source that detects multiple analytes, all from the same micro-sample of blood.
The OptiScanner 6000 is the only automated, bedside blood monitoring system to accurately measure and trend plasma-based glucose and lactate, without the need for calibration.
Pivotal study results published in the Journal of Trauma and Acute Care Surgery – June, 2017
OptiScan featured in front page article in Medical Device Daily – “Optiscan’s near continuous multianalyte monitoring device gains CE marking” – January 9, 2017
MANAGE IDE preliminary study results were presented at AAST in September 2016. Grant Bochicchio, primary investigator (Chief, Acute and Critical Care Surgery, Washington University School of Medicine, St Louis), said, “We are excited to have met both primary and secondary endpoints, but even more meaningful is the positive impact this innovation will have on clinical practice and patient outcomes.”
“MANAGE vs automated monitoring accuracy of Glucose II (MANAGE II)” – European study published in Critical Care – 2016 (20:380).
Results: MARD = 7.7%. Clarke Error Grid (CEG) was 99.9% in zones A and B.
OptiScan Biomedical Completes Enrollment of Pivotal U.S. Clinical Study of the OptiScanner 5000 System – November 2015
OptiScan Biomedical has received CE Mark certification for the OptiScanner 5000/6000 system.