OptiScan Biomedical

OptiScan Biomedical Corporation is a medical device company focused on developing and commercializing automated, bedside monitoring systems for use in hospital intensive care units (ICUs). Founded in 1994, the company aims to provide clinicians with tools to rapidly detect changes in the condition of critically ill patients, thereby enabling more timely intervention. The company's headquarters are in Hayward, California.

The company's core technology is the OptiScanner platform, which utilizes mid-infrared spectroscopy to analyze micro-samples of blood. The flagship product, the OptiScanner 5000, is an automated system designed for the continuous monitoring of glucose levels in plasma. This system draws a small blood sample every 15 minutes, processes it in a micro-centrifuge, and provides real-time glucose readings without the need for manual calibration. The device is intended to help manage glycemic control in surgical ICU patients, alerting clinicians to conditions like hyperglycemia and hypoglycemia. A key differentiator is its measurement of glucose in plasma rather than whole blood, which can minimize interference effects.

Peter Rule served as the Chairman of the Board since 2001 and as CEO from 2006 until 2017. His extensive background includes leadership roles at other successful medical device companies such as MiniMed, PercuSurge, and EKOS Corporation, and he co-founded Therasense, which developed the Freestyle glucose meter. In May 2018, Cary G. Vance was appointed President and CEO, bringing experience from his leadership roles at Myoscience and Hansen Medical. OptiScan has received significant financial backing, raising a total of $220 million over 11 funding rounds from investors including NGN Capital, MedVenture Associates, and Johnson & Johnson Innovation. A major milestone was achieved in October 2017, when the OptiScanner 5000 received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in surgical ICUs. The company has also developed next-generation systems, the OptiScanner 6000 and 7000, which expand the monitoring capabilities to include lactate and central venous oxygen saturation (ScvO2), key analytes for managing sepsis. These advanced models have received CE Mark approval in Europe. Keywords: continuous glucose monitoring, ICU patient monitoring, medical device, bedside monitoring, plasma glucose, spectroscopy, critical care, glycemic control, hyperglycemia management, hypoglycemia detection, lactate monitoring, ScvO2 monitoring, sepsis management, FDA 510(k) clearance, CE Mark, medical technology, automated blood analysis, critical patient care, hospital diagnostics, real-time monitoring