The FDA has issued a “It Has Come to Our Attention Letter” to India-based Biosense Technologies, surrounding the company's uChek Urine Analyzer app.
The app allows users to analyze their urinalysis dipsticks at home via mobile phone.
"Everybody pees, and everybody carries a cellphone," explains Myshkin Ingawale, the co-founder of med tech company Biosense Technologies. "We figured we had to be able to do something with this."
The uChek system works only with test strips that are manufactured by Siemens and Bayer, which have received FDA clearance for visual reading, but need further approval for automated analysis.The FDA letter said that any company planning to promote its medical device for analysing, reading and interpreting these dipsticks should get clearance for the complete urinalysis test system, which includes the strip reader and the test strips.
FDA issued draft guidance in 2011 around mobile medical applications. This is the first direct citation of a mobile medical app since then. Read more.