Myshkin Ingawale, co-founder of Biosense Technologies, a med tech company based in Mumbai, India, along with partners Dr Abhishek Sen, Dr Yogesh Patil, and Aman Midha, have developed uChek, an Android and iPhone mobile app that analyzes urine for the presence of 25 different medical conditions. Ingawale presented uChek at the TED (Technology, Education and Design) 2013 conference in Los Angeles this month.
uChek consists of two components – uChek smartphone app and the uChek kit which consists of the uChek color mat and five sample urine dipsticks. A standard urine test strip may comprise up to 10 different chemical pads or reagents which react and hence change color when immersed in, and then removed from, a urine sample. The readings can be obtained between 60 and 120 seconds of dipping, and will detect the presence of up to 25 diseases, including diabetes, pre-clampsia, urinary tract infection, among others.
Biosense previously developed the ToucHb, a hand-held needle-free battery operated device that enables screening for anaemia and simplifies monitoring of treatment on a regular basis. ToucHb was developed as a platform technology with the possibility to integrate with mobile devices using platforms such as Android, and the ability to extend similar principles of operation to diagnose other conditions, and investigate other blood anylates.
The uChek app uses the iPhone or Android camera to perform a colormetric analysis of the urine sample. The mobile app compares the photographed dipstick with a color-coded map in the software, then presents easy-to-read reports displaying glucose levels, bilirubin, proteins, ketones, leukocytes and other parameters.
Early testing of the device included 1200 patients, and indicated the results are more accurate that a human comparison by eye, and is currently awaiting approval by Apple for distribution in the App Store. The app is currently undergoing testing in a Mumbai hospital.
Ingawale aims to revolutionize the medical device industry by helping consumers better understand what is happening in their own bodies. “I wanted to get medical health checks into users’ hands. There is huge potential to get the world of biochemistry out to users via apps,” he told BBC.
Regulatory bodies around the world, including the U.S. Food and Drug Administration are closely monitoring the mHealth market, which operates similarly to the unregulated health supplement industry, and plan to establish new regulations and standards.
“There are about 40,000 health apps available for smartphones or tablets, produced by doctors, software developers, pharmaceutical companies and hospital systems, among others. The mobile health market is expected to reach $392 million in 2015, according to global industry analyst and consultancy firm Frost & Sullivan,” Cleveland Plain Dealer’s Brie Zeltner wrote in a report on the industry that was published Sunday.
“The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:
- are used as an accessory to medical device already regulated by the FDA (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
- transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
In a Consumer Update, FDA policy advisor Bakul Patel says some of the new mobile apps are designed to help consumers manage their own health and wellness—like the National Institutes of Health’s LactMed app, which gives nursing mothers information about the effects of medicines on breast milk and nursing infants.
Other apps are aimed at helping health care providers improve and facilitate patient care—like the Radiation Emergency Medical Management (REMM) app, which gives health care providers guidance on diagnosing and treating radiation injuries. There are even apps to aid diagnosis of rashes and heart irregularities.
FDA has already cleared a handful of mobile medical apps used by health care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays.
“There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” Patel says. “Apps can give consumers valuable health information in seconds and are opening innovative ways for technology to improve health care. However, the small group of mobile medical apps FDA proposes to oversee present a potential risk—these apps may impact how a currently regulated medical device (such as an ultrasound) performs,” he adds.
Medical apps like the uChek will remain readily accessible through mobile application download services, such as Apple’s App Store until FDA and other agencies release new regulations. An iPhone urinalysis app, “Piddle” was previously released at the App Store, with others under development, and a number of blood glucose monitoring apps for diabetics already populate the App Store.