Biosense Technologies (India) has developed a mobile urine lab known as uChek that was accepted into Apple's App Store. The product, however, was not submitted to FDA for regulatory clearance, and the agency has issued a letter to the company urging them to do so. This marks the first time that the agency has issued such a warning to a maker of mobile-enabled health-monitoring product. The app tests for 25 medical conditions ranging from diabetes to urinary tract infections.
"We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world," said Abhishek Sen, co-founder of Thane, India-based Biosense, wrote in an e-mail to Bloomberg.
In other news, AgaMatrix (Salem NH), which developed the iPhone-connected glucose meter known as the iBGStar, has received clearance from the FDA for its iBGStar glucose meter, which can now works with the iPhone 5 and the fifth generation of the iPod Touch using a new adaptor that works with Apple's Lightning connector.
In addition, iPhone ECG maker AliveCor (San Francisco) has won a nod from the regulatory agency for its iPhone 5-compatible version of its flagship product, which uses an electrode-equipped case to detect patients' ECG readings.