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FDA Questions Lack Of 510(k) For uChek Urinalysis App

This article was originally published in The Gray Sheet

Executive Summary

In a letter sent to manufacturer Biosense Technologies, FDA strongly suggests that the uChek system, which relies on an app employing a smartphone camera to read urine dipsticks, is running afoul of pre-market device regulations.

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Optometrists Group Says FDA Should Regulate Online Eye-Test Provider

Opternative allows consumers to take an eye test via their computer or smartphone, practices the American Optometric Association said could pose a risk to patient safety. The trade group wants FDA to require an approval for the service.

Optometrists Say FDA Should Regulate Online Eye-Test Provider

Opternative allows patients to take an eye test via their computer or smartphone, which the American Optometric Association said could pose a risk to patient safety. The trade group wants FDA to require an approval for the service.

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