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The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone
uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone into a medical device, designed to read urinalysis test strips that are normally examined by users and compared to a color-coded chart.
With the uChek system, patients can take a picture of the strip with the iPhone's camera and then receive an automated readout of parameters like glucose, urobilinogen, pH, ketone and more. The app also stores results which then can be analyzed over time.
Though medical device makers have adopted the iPhone for some measurements like
blood glucose monitoring for diabetics, large scale use of smartphones and tablets as a replacement for existing medical devices has yet to take off -- likely due in large part to government regulation of medical devices.
From Bloomberg:
The uChek kit can be
purchased in the US and India for $40, while the uCheck iPhone app is a
free download [
Direct Link] from the App Store -- though the app can also manually read urine strips from other companies.
Article Link:
iPhone Urinalysis App Draws U.S. Government Scrutiny