A Mumbai-based medical technology firm has been asked by the US Food and Drug Administration to explain why it had not taken approval from the agency prior to releasing an app through which users can analyze their urine samples from their smartphones.
The firm, Biosense, had developed an app known as uChek for iPhone through which smartphone users can analyze snapshots of their urine samples to detect a number of diseases, including diabetes, urinary tract infection and hepatitis.
However the FDA has sent a notice asking that as the app converted the user's phone into an automated strip reader, why did not the company seek FDA's approval before its release.
Biosense acknowledged that they have been contacted by the FDA and its co-founder, Myshkin Ingawale said that his company will be working close with the health regulatory body to ensure that they provide an accurate diagnostic tool. "We are in communication with the FDA as per their latest letter, and will be working closely with them over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world", he said.