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
iOS 19 will not be available on the iPhone XR, iPhone XS, or the iPhone XS Max, according a private account on social media site X that has accurately provided information on device compatibility in the past.
The iPhone XR, iPhone XS, and iPhone XS Max all have an A12 Bionic chip, so it looks like iOS 19 will discontinue support for that chip. All other iPhones that run iOS 18 are expected...
Apple today released watchOS 11.4, the fourth major update to the operating system that runs on the Apple Watch. watchOS 11.4 is compatible with the Apple Watch Series 6 and later, all Apple Watch Ultra models, and the Apple Watch SE 2.
watchOS 11.4 can be downloaded on a connected iPhone by opening up the Apple Watch app and going to General > Software Update. To install the new software,...
Apple today released new firmware updates for all AirPods 4 and AirPods Pro 2 models. The new firmware is version 7E93, up from the 7B21 firmware that was installed on the AirPods Pro 2 and the 7B20 firmware available on the AirPods 4 and AirPods 4 with ANC.
It is not immediately clear what new features or changes are included in the new firmware, but we'll update this article should we find ...
Apple today released iOS 18.4 and iPadOS 18.4, the fourth major updates to the iOS 18 and iPadOS 18 operating system updates that came out last year. iOS 18.4 and iPadOS 18.4 come two months after Apple released iOS 18.3 and iPadOS 18.3.
Subscribe to the MacRumors YouTube channel for more videos.
The new software can be downloaded on eligible iPhones and iPads over-the-air by going to...
While the iPhone 17 Pro and iPhone 17 Pro Max are not expected to launch until September, there are already plenty of rumors about the devices.
Below, we recap key changes rumored for the iPhone 17 Pro models as of March 2025:
Aluminum frame: iPhone 17 Pro models are rumored to have an aluminum frame, whereas the iPhone 15 Pro and iPhone 16 Pro models have a titanium frame, and the iPhone ...
Visa wants to pay Apple approximately $100 million to be the new payment network for the Apple Card, reports The Wall Street Journal. As of right now, the Apple Card is on the Mastercard payment network, but that is set to change because Apple is ending its partnership with Goldman Sachs.
Both American Express and Visa are vying to replace Mastercard as Apple's card services provider, while...
Apple today seeded the first betas of upcoming iOS 18.5 and iPadOS 18.5 updates to developers for testing purposes, with the software coming just two days after Apple released iOS 18.4 and iPadOS 18.4.
iOS 18.5 and iPadOS 18.5 can be downloaded from the Settings app on a compatible device by going to General > Software Update.
We don't yet know what Apple is introducing in the iOS 18.5...