Sphere Medical’s core microanalyser technology is based on a pair of silicon chips, one with a sensor array, the second containing the electronics required to control the sensors. The company supports a broad portfolio of patents covering aspects of manufacture, materials and applications. The majority are granted in the US, Europe and Japan and the company continues to actively extend the patent portfolio.
The microanalyser has been validated in extensive laboratory and clinical testing to give a performance equivalent to that of standard clinical laboratory analysers. An in-vitro analyser incorporating the technology to measure glucose, pH, carbon dioxide, oxygen and potassium ions in patient blood samples has received 510(k) clearance from the FDA, and will be a predicate device for future product approvals.