The Federal Drug Administration (FDA) has sent a letter to Biosense Technologies, makers of the "uChek Urine Analyzer" to clarify why they have not asked for the approval of the FDA before releasing the diagnostic mobile app.
The uChek mobile app provides users health information based on its analysis of images of urine samples. It claims to help diagnose urinary tract infection, hepatitis, and diabetes.
FDA dinged uChek
In its letter to the company sent last Tuesday, the FDA told the company headquartered in Mountain View, California that it has 30 days to explain why the mobile app does not need the approval of the agency or show that the company already has its approval.
"We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer. We request that you provide us with the FDA clearance number for the uChek Urine analyzer. If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination," the correspondence signed by FDA Deputy Director James Woods stated.
The letter from the FDA also clarified that while Biosense has its clearance to use urinalysis dipsticks, they are only meant to be interpreted using direct visual analysis. Since the company makes use of a smartphone and mobile app, the setup can be classified as an automated strip reader.
"Any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together," the letter said.
A Welcome Development
In an email sent to Los Angeles Times, Biosense co-founders Myshkin Ingwale and Abhishek Sen confirmed that they had received the letter and that the company intends to cooperate with the FDA to ensure that they continue to provide convenient, affordable, and accurate diagnostics to the local and global market.
Experts see the FDA move as a welcome development since mobile apps used for diagnostics may provide inaccurate information and have serious consequences if used improperly. This will also make sure that me-too versions of such apps will not be easily rolled out. From the perspective of investors, an FDA approval also increases the valuation of companies that can provide accurate apps.
While new technologies may help consumers, medical-related mobile apps may also put them in a very dangerous situation. Imagine what can happen to someone with very high or low blood sugar level that has been misinterpreted by a poorly calibrated app. Another good example will be a chest X-ray reading done on a mobile device that has a small screen that is not really designed for such purpose. A previous study published on the Journal of Telemedicine and Telecare showed that about 86 of 100 apps tested did not have the involvement of healthcare professionals during development.
In a blog published on FDA Voice last March, the FDA took note of the growing number of mobile apps intended for diagnostic purposes. It took note of apps capable of doing an electrocardiogram, function as a stethoscope, or help doctors view X-rays.
The agency does not intend to block innovations in the health care industry but intends to do its job of regulating mobile apps that aim to function as a diagnostic tool or serve as accessories to medical devices, which fall under the ambit of regulation by the agency.
