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Food and Drug Administration Sends Letter to Biosense Technologies Regarding Urinalysis Phone App

After months of complaints from experts that the uCheck app is a medical device that failed to seek FDA approval, the U.S. Food and Drug Administration send a letter this week to Biosense Technologies, the maker of uChek smartphone-enabled unrinanalysis system instructing it to seek 510(k) clearance of its mobile medical application or to convince the FDA that such clearance is not necessary. James Woods a deputy director with the FDA, stated in the letter, “Please note that though the types of urinalysis dipsticks…
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