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.
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.
Popular Stories
We're getting closer to the launch of the final major iOS update of the year, with Apple set to release iOS 26.2 in December. We've had three betas so far and are expecting a fourth beta or a release candidate this week, so a launch could follow as soon as next week.
Past Launch Dates
Apple's past iOS x.2 updates from the last few years have all happened right around the middle of the...
Apple is encouraging iPhone users who are still running iOS 18 to upgrade to iOS 26 by making the iOS 26 software upgrade option more prominent.
Since iOS 26 launched in September, it has been displayed as an optional upgrade at the bottom of the Software Update interface in the Settings app. iOS 18 has been the default operating system option, and users running iOS 18 have seen iOS 18...
Apple is expected to launch a new foldable iPhone next year, based on multiple rumors and credible sources. The long-awaited device has been rumored for years now, but signs increasingly suggest that 2026 could indeed be the year that Apple releases its first foldable device.
Subscribe to the MacRumors YouTube channel for more videos.
Below, we've collated an updated set of key details that ...
Apple today seeded the release candidate versions of upcoming iOS 26.2 and iPadOS 26.2 updates to developers and public beta testers, with the software coming two weeks after Apple seeded the third betas. The release candidates represent the final versions of iOS 26.2 and iPadOS 26.2 that will be provided to the public if no further bugs are found during this final week of testing....
Apple's iPhone 17 lineup is selling well enough that Apple is on track to ship more than 247.4 million total iPhones in 2025, according to a new report from IDC.
Total 2025 shipments are forecast to grow 6.1 percent year over year due to iPhone 17 demand and increased sales in China, a major market for Apple.
Overall worldwide smartphone shipments across Android and iOS are forecast to...
In a statement shared with Bloomberg on Wednesday, Apple confirmed that its software design chief Alan Dye will be leaving. Apple said Dye will be succeeded by Stephen Lemay, who has been a software designer at the company since 1999.
Meta CEO Mark Zuckerberg announced that Dye will lead a new creative studio within the company's AR/VR division Reality Labs.
On his blog Daring Fireball,...
2026 could be a bumper year for Apple's Mac lineup, with the company expected to announce as many as four separate MacBook launches. Rumors suggest Apple will court both ends of the consumer spectrum, with more affordable options for students and feature-rich premium lines for users that seek the highest specifications from a laptop.
Below is a breakdown of what we're expecting over the next ...
The iPhone Air has recorded the steepest early resale value drop of any iPhone model in years, with new data showing that several configurations have lost almost 50% of their value within ten weeks of launch.
According to a ten-week analysis published by SellCell, Apple's latest lineup is showing a pronounced split in resale performance between the iPhone 17 models and the iPhone Air....
iPhone 17 Pro models, it turns out, can't take photos in Night mode when Portrait mode is selected in the Camera app – a capability that's been available on Apple's Pro devices since the iPhone 12 Pro in 2020.
If you're an iPhone 17 Pro or iPhone 17 Pro Max owner, try it for yourself: Open the Camera app with Photo selected in the carousel, then cover the rear lenses with your hand to...
OpenAI is deprioritizing work on advertising as it focuses on improving the quality of ChatGPT, reports The Information. OpenAI CEO Sam Altman declared a "code red" on Monday, and told employees that the company needs to improve ChatGPT so it doesn't fall behind competitors like Google and Anthropic.
Altman said that OpenAI needs to work on personalization for each user, image generation,...
