The FDA sent a letter to the developer of a smartphone app that checks urine.
Last May 21, the FDA sent Biosense Technologies Private Limited a letter of notice. The company uses technology to develop different diseases and one of them is uCheck Urine Analyzer-- a smartphone app that can scan photos and detect diseases based on the input. However, the agency requires the app to obtain regulatory approval from them because even if the urine strips used are the ones used in the hospitals, the agency approved it only for visual analysis and not for scanned analysis.
The uCheck app was designed for those people who is not comfortable having themselves checked by a doctor. Users will need to buy test strips from the pharmacy and dip it in their urine. They will then take a photo of the strip and upload it on the app. The app will then analyze the urine based on the color and pigmentation of the photo before it displays the results.
The FDA also mentioned in their letter that if uCheck would want to have the app approved, the manufacturer of the test strips-Siemens and Bayer-will need to process additional clearances to have the product certified for scanned test.
Biosense co-founders Abhishek Sen and Myshkin Ingawale confirmed that they have received the letter and promised to comply with the requirements needed by the FDA to ensure quality and accurate diagnostics internationally. All discussions will be kept confidential until such time that they have finalized the requirements.
Biosense has 30 days to respond to the letter. To have a view of the letter, click
FDA's target this year are the medical apps especially those that may pose risk to the consumers who might be provided incorrect analysis.
