Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests
Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens
Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.
The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. (more…)