OptiScan Biomedical, a company based in Hayward, California, won FDA clearance to introduce its OptiScanner 5000 in the U.S. The device is intended for use in intensive care units to continuously monitor blood plasma glucose levels, something the OptiScanner 5000 can do accurately without having to be regularly calibrated. The device works via an integrated blood centrifuge and spectrometer to provide directly measured plasma-based glucose levels in critically ill patients.
The OptiScanner 5000 relies on a single-use disposable cartridge that is swapped out for every patient. Once activated, clinicians can see both real-time glucose measurements, as well as trends over time. This helps to quickly identify cases of hypoglycemia, hyperglycemia, and helps to assess patient glycemic variability.
The device is already approved for clinical use by the European Union.
Here’s a bit from OptiScan regarding the clinical trial that led to the FDA clearance:
The clearance by FDA was based on results from OptiScan’s pivotal, multi-center clinical trial in 160 surgical intensive care unit patients comparing the accuracy of the OptiScanner 5000 to industry standard glucose measurement in the ICU. Results from the study demonstrated the OptiScanner 5000 to be safe and accurate for use in patients in the surgical intensive care unit. As with other previously completed clinical studies of the OptiScanner 5000, these pivotal study results highlighted the ability of the device to combine accurate plasma glucose measurement with the convenience of continuous, real-time bedside monitoring, and alarms which notify clinicians of excursions from the desired glucose range.
Product page: OptiScanner 5000…
Via: OptiScan Biomedical…