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've been focusing on deals on physical products over the past few weeks, but Black Friday is also a great time of year to purchase a streaming membership. Some of the biggest services have great discounts for new and select returning members this week, including Disney+, Hulu, Paramount+, Peacock, and more.
Note: MacRumors is an affiliate partner with some of these vendors. When you click a...
iOS 27 will reportedly have two major elements: quality improvements and new AI features.
In his Power On newsletter today, Bloomberg's Mark Gurman said that iOS 27 will be similar to Mac OS X Snow Leopard, in the sense that Apple is focused on improving "quality and underlying performance" over adding new features.
Gurman said there is one exception to this rule, though, as he expects...
iOS 26.2 is currently in beta testing. The upcoming update includes a handful of new features and changes on the iPhone, including a new Liquid Glass slider for the Lock Screen's clock, offline lyrics for Apple Music, and more.
In a recent press release, Apple confirmed that iOS 26.2 will be released to all users in December, but it did not provide a specific release date.
Keep reading...
We're only a few days away from Black Friday, which will take place on Friday, November 28 in 2025. As always, this will be the best time of the year to shop for great deals, including popular Apple products like AirPods, iPad, Apple Watch, and more. In this article, the majority of the discounts will be found on Amazon.
Note: MacRumors is an affiliate partner with some of these vendors. When...
On this week's episode of The MacRumors Show, we talk through all of the new features and improvements expected to come to next year's iPhone 18 Pro and iPhone 18 Pro Max models.
Subscribe to The MacRumors Show YouTube channel for more videos
Apple's next-generation iPhones are less than ten months away and we already have a good idea about what to expect based on corroborated leaks, rumors,...
American multinational news company CNN has abruptly pulled its content from Apple News, Semafor reports.
CNN quietly removed its stories from Apple News over the weekend and there is no longer a feed from the network to subscribe to in the app. This effectively ends its distribution agreement with Apple while the two sides negotiate new terms. Discussions are apparently ongoing and CNN's...
Black Friday deals have begun, and Amazon is one of the best places you can find steep discounts on numerous products this week. We've already collected all of the best Apple-related deals you'll find at Amazon (and other retailers) in our Apple Black Friday Deals post, so below you'll find other discounts on devices like Anker accessories, Beats headphones, video games, TVs, and more.
Note:...
Apple's annual four-day Black Friday through Cyber Monday shopping event is returning on Friday, November 28 through Monday, December 1 in many countries, including the United States, Canada, Australia, New Zealand, France, Germany, Italy, Spain, the United Kingdom, Belgium, the Netherlands, Sweden, Thailand, and others.
During the shopping event, customers can get an Apple gift card with...
Apple's first foldable iPhone is expected to launch alongside the iPhone 18 Pro models in fall 2026, and it's shaping up to include three standout features that could set it apart from the competition.
The book-style foldable will reportedly feature an industry-first 24-megapixel under-display camera built into the inner display, according to a recent JP Morgan equity research report. That...
