Mumbai-based medical devices startup Biosense Technologies Pvt Ltd, which has recently launched its second product called uChek app that enables physicians and patients to analyse urine samples using their smartphones, has received a letter from US Food and Drug Administration to get FDA clearance for the app as it is available for iPhone users in the US.
The uChek app helps in the process of visual inspection, providing time-keeping and manual data logging functionality. In its advanced (auto) mode, the app turns the smartphone's camera into dipstick reader which detects the colour change and the medical condition automatically. The app can read about 25 medical conditions, including kidney, liver and bladder problems, urinary tract infections, pre-eclampsia and complications of diabetes.
"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)," reads FDA's letter.
"I won't be able to comment on FDA's communication, but we are registered with the FDA and we are in process of classifying the appropriate category for the product as mobile app-related health solutions are new to FDA as well," said Myshkin Ingawale, CEO and co-founder of Biosense.
According to FDA, the association has reviewed the files and did not find FDA clearance number for the uChek urine analyser. It has requested the startup to provide either the FDA clearance number for uChek or in case the company does not believe that it is required to obtain FDA clearance, it should provide the basis for that determination to FDA within 30 business days.
Biosense is an incubatee of Centre of Innovation, Incubation and Entrepreneurship (CIIE) at IIM-Ahmedabad. It has been founded by the four-member team of Ingawale (CEO), Abhishek Sen, Yogesh Patil (COO) and Aman Midha.
The company belonged to the first batch of startups incubated by GSF India and Sawhney-promoted Global Super Angels Forum which put in $150K in the firm in March 2012. As part of that investment, Samir Sood, a member of Global Super Angels, also joined the board of the company. Biosense had earlier secured seed funding from the Echoing Green Foundation and Chennai-based Villgro, an organisation that invests in early-stage social startups.
(Edited by Sanghamitra Mandal)