iPhone Urinalysis App Draws U.S. Government Scrutiny

The U.S. Food and Drug Administration has sent a letter to BioSense Technologies over its iPhone uChek urinalysis system, asking why its medical app hasn't been cleared by the agency. The app is one of the first that turns the iPhone into a medical device, designed to read urinalysis test strips that are normally examined by users and compared to a color-coded chart.

With the uChek system, patients can take a picture of the strip with the iPhone's camera and then receive an automated readout of parameters like glucose, urobilinogen, pH, ketone and more. The app also stores results which then can be analyzed over time.

Uchek
Though medical device makers have adopted the iPhone for some measurements like blood glucose monitoring for diabetics, large scale use of smartphones and tablets as a replacement for existing medical devices has yet to take off -- likely due in large part to government regulation of medical devices.

From Bloomberg:

Biosense Technologies Private Ltd.’s uChek system isn’t cleared by the Food and Drug Administration and the agency said it wants to know why not, in a first-of-its-kind letter to a maker of a mobile-device application. The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to processes and generate automated results.

UChek works with test strips made by Siemens AG (SIE) and Bayer AG (BAYN), which are only approved for visual reading and require new clearance for automated analysis, the FDA said in the letter. The agency has said it wants stricter rules for apps that directly diagnose or treat conditions, proposing in 2011 to apply similar quality standards as for heart stents, ultrasound machines and other medical devices.

The uChek kit can be purchased in the US and India for $40, while the uCheck iPhone app is a free download [Direct Link] from the App Store -- though the app can also manually read urine strips from other companies.

Top Rated Comments

macaddict06 Avatar
118 months ago
Good idea, but valid point

As a medical professional (in training) I'm always excited to see the use of iOS devices to make monitoring easier. Patients in rural areas are particularly disadvantaged in the monitoring area, so new apps like this help to level the playing field.

That said, I'm glad that the FDA is keeping tabs on apps - the last thing that anyone wants are patients/healthcare providers making decisions based on results from un-vetted apps.

I'm sure that the Urinalysis App has great intentions, but there is an acceptance process for a reason.
Score: 19 Votes (Like | Disagree)
Sayer Avatar
118 months ago
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.
Score: 17 Votes (Like | Disagree)
NutsNGum Avatar
118 months ago
Cue class action from consumer group that have number 1'd all over their phone.
Score: 14 Votes (Like | Disagree)
mytdave Avatar
118 months ago
.|..

Easy answer. "It's not a medical device, it's a personal-use experimental tool" so go ****** youself FDA.
Score: 12 Votes (Like | Disagree)
topmounter Avatar
118 months ago
This is front page worthy? Seriously?
Score: 11 Votes (Like | Disagree)
iSee Avatar
118 months ago
The real reason is so that the Federal Government can tax this app's sales. Besides all it does is take a photo of an already-approved (taxed) test strip and include a database function. It does not perform any actual tests itself like a blood-glucose meter does.

If the government was all about safety then Tobacco would be banned and we'd have 100% self-driving cars by now.

Woah, there cowboy!

The govenment doesn't need to use the FDA to tax anything, so you are making no sense. And there are several things that could go wrong here. The camera needs to be working well enough, the app needs to process the image correctly and display the results correctly. The FDA approval process should ensure that uChek has put into place sufficient quality control and verification.

The Tobacco and self-driving car stuff is important stuff, but completely irrelevant... If you are concerned about those, you should be posting comment on stories with some relation to those topics.
Score: 10 Votes (Like | Disagree)

Popular Stories

iPhone 14 Purple Lineup Feature

Will the iPhone 14 Be a Disappointment?

Saturday May 21, 2022 9:00 am PDT by
With around four months to go before Apple is expected to unveil the iPhone 14 lineup, the overwhelming majority of rumors related to the new devices so far have focused on the iPhone 14 Pro, rather than the standard iPhone 14 – leading to questions about how different the iPhone 14 will actually be from its predecessor, the iPhone 13. The iPhone 14 Pro and iPhone 14 Pro Max are expected...
apple ar headset concept 1

Apple's Headset Said to Feature 14 Cameras Enabling Lifelike Avatars, Jony Ive Has Remained Involved With Design

Friday May 20, 2022 6:50 am PDT by
Earlier this week, The Information's Wayne Ma outlined struggles that Apple has faced during the development of its long-rumored AR/VR headset. Now, in a follow-up report, he has shared several additional details about the wearable device. Apple headset render created by Ian Zelbo based on The Information reporting For starters, one of the headset's marquee features is said to be lifelike...
sony headphones 1

Sony's New WH-1000XM5 Headphones vs. Apple's AirPods Max

Friday May 20, 2022 12:18 pm PDT by
Sony this week came out with an updated version of its popular over-ear noise canceling headphones, so we picked up a pair to compare them to the AirPods Max to see which headphones are better and whether it's worth buying the $400 WH-1000XM5 from Sony over Apple's $549 AirPods Max. Subscribe to the MacRumors YouTube channel for more videos. First of all, the AirPods Max win out when it comes ...
apple music

Apple Increases Apple Music Subscription Price for Students in Several Countries

Sunday May 22, 2022 1:57 am PDT by
Apple has silently increased the price of its Apple Music subscription for college students in several countries, with the company emailing students informing them their subscription would be slightly increasing in price moving forward. The price change is not widespread and, based on MacRumors' findings, will impact Apple Music student subscribers in but not limited to Australia, the...
iPhone 13 Face ID

'High-End' iPhone 14 Front-Facing Camera to Cost Apple Three Times More

Monday May 23, 2022 7:05 am PDT by
The iPhone 14 will feature a more expensive "high-end" front-facing camera with autofocus, partly made in South Korea for the first time, ET News reports. Apple reportedly ousted a Chinese candidate to choose LG Innotek, a South Korean company, to supply the iPhone 14's front-facing camera alongside Japan's Sharp. The company is said to have originally planned to switch to LG for the iPhone...