October 7, 2014
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...
December 12, 2013
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...
September 12, 2013
Crowdfunding is alive and well in mobile health. Just a few months after Scanadu's record-breaking presale, a number of mobile and digital health companies continue to turn to Indiegogo and Kickstarter to fund projects. Over the last few months, MobiHealthNews has written about Emotiv, Beddit, uCheck, and Eclipse.
EEG-tracking headset Emotiv still has three days left in its campaign, but the...
May 30, 2013
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...
May 25, 2013
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,...
May 23, 2013
So far this past week was a busy one for those at the FDA's device office focused on mobile medical app regulation. No, it didn't release its final guidance document yet, even though Congress gave the agency a verbal lashing more than three months ago now. Still, the agency has had an unusually busy week.
Apart from the typical -- like Rock Health alum Nephosity securing FDA 510(k) clearance for...
May 22, 2013
This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the...
February 28, 2013
One of the many promises of mobile health is self-diagnosis, and for informational medical tests that are easy to perform at home, it's hard to beat urinalysis. One of the most ubiquitous home diagnosis devices of the last century, the home pregnancy test, is a consumer urine test. But although the first home pregnancy test was patented in 1968, it's taken until recently for the many other uses...