Phillips-Medisize is collaborating with healthcare start-up SOTECH Health to accelerate the development of a breath-sensor system that detects COVID-19 in less than 30 seconds. This a reusable device that leverages research at the University of Texas into cloud-based Artificial Intelligence (AI) and Phillips-Medisize’s “product design, rapid prototyping, and end-to-end manufacturing expertise”.
To screen for COVID-19, a person breathes into the device for six seconds, then a sensitive, electrochemical sensor looks for traces of certain chemicals in the sample. Results are available in 30 seconds, and SOTECH Health has already conducted 31,000 tests using its device. Each new product prototype has been executed with a focus on continuous improvement and quality, resulting in a validated product design ready for swift production ramp.
The test has been submitted for emergency-use authorisation approval by the FDA and is awaiting regulatory approvals from Health Canada, the MHRA and the EU’s In Vitro Diagnostic (IVDD) self-declare, and then IVDR once regulations are applicable.