Urine analysis app uChek is about to launch a six-month, 375-patient trial with Merck for Mothers, a Merck-sponsored initiative to reduce global maternal mortality, according to ClinicalTrials[dot]gov. Researchers will test the feasability of providers using uChek to detect preeclampsia and eclampsia in pregnant women in Bangladesh, with usability of the app for healthcare professionals as a...
vitaMe's prototype Nutriphone device
Nutriphone, a smartphone accessory developed at Cornell University by two PhD students, enables users to test cholesterol levels, saliva pH, vitamin deficiency and more, vitaMe Technologies CTO Vlad Oncescu explained during a panel discussion at the mHealth Summit outside of Washington DC this week.
"The one area [in health sensors] that hasn't been...
Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urine analysis system, has already had a busy year.
Its cofounder appeared onstage at TED. Its uChek system was held up as an example of FDA's lack of enforcement in a Congressional hearing in March. The FDA subsequently took the rare action of sending the company a warning letter about uChek that...
Following MobiHealthNews' coverage of the rare action that FDA took last week by sending a medical app developer an "It has come to our attention" letter that instructs it to seek 510(k) clearance for its urine analysis app, two readers wrote in to point out that Biosense Technologies, the maker of the app, had indeed already registered it as a Class I medical device with the FDA. The company...
By Bradley Merrill Thompson
As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry.
Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly,...
