Got an iPhone? Now you can perform your own high-tech urine analysis, thanks to an app that’ll let you analyze blood, protein, and certain other substance levels in your urine.
It sounds a bit outré, and that’s not far off the mark; Biosense Technologies Private Ltd. now faces questions from the U.S. Food and Drug Administration because its uChek app system is being marketed despite not having been cleared by the FDA first.
This is the first such interchange between the world of biotech and the world of smartphones. The uChek system allows users to test urine by dipping test strips in urine and then allow the iPhone’s camera to begin processing.
The strip, as the L.A. Times reports, changes color in response to the chemical composition of the urine sample. A color mat, positioned under the strip, provides for baseline readings. That’s how the iPhone can provide a summary analysis of the urine contents.
The problem is that these dipsticks are usually used by medical professionals for direct visual analysis; the new system basically requires the FDA to re-issue clearance for such usage.
The L.A. Times provides an excerpt of the FDA’s letter:
“When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system,” FDA Deputy Director James Woods wrote in the letter. “Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).”
Biosense has 30 days to either cooperate with the FDA and request clearance or explain why the uChek system does not require clearance. Thus far, the company has simply acknowledged receipt of the letter and expressed intent to correspond with the FDA, reports Bloomberg.
Medical apps have mushroomed in recent months as smartphones take firmer roots in the social structure of developed nations. We’re already comfortable making digital deposits simply by taking a snapshot of a check. And we can scan product barcodes in a store to determine if we’re getting the best value for our money.
The growing number of medical apps has already caused the FDA to perk up and pay attention; early in 2013, the agency stated that it would be focusing on apps that might inadvertently endanger patients through misleading information. In general, it’s clear that the FDA is observing this new phenomenon closely, and it will likely tighten medical app oversight.
Early Winners
It’s not all bad news, though, and you should definitely continue to monitor this emergent sector closely. For example, the “digital health” startup Nephosity has just received 510(k) approval from the FDA to commercialize its mobile app for diagnostic purposes.
Nephosity’s app is basically a mobile image viewing app that would allow clinicians to view and analyze CT scans, MRIs, and X-Ray images in absence of the conventional viewing devices. The app, reports Med City News, networks with the hospital’s picture archives in order to retrieve the relevant images, and the picture can be manually manipulated (zoomed in upon, magnified, and so on). The app is presently going through final stages of refinement.
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And it doesn’t stop there. Nephosity is also developing a cloud-based storage platform, Jack Imaging, which would permit the medical images to be stored, shared, and accessed at any time. The implications are fairly obvious—and very encouraging.
Much like how cloud storage has radically changed workflows (virtual projects in offices are now routine practice), the combination of Nephosity’s imaging app and cloud storage could open the gateway toward collaborative diagnostics. In cases where medical professionals are not located together spatially, they could simply access the images in the cloud and work together on analysis and diagnostics.
Digital healthcare, much like robotic healthcare, is a growing sector. The FDA will toward greater oversight isn’t necessarily a bad thing; you’d certainly want to be able to trust an app when it comes to crucial health matters. However, if the FDA tightens rules too far, then the growth of this new market may be stifled somewhat.
It’s worth your while to keep an eye on developments in this sector, paying particular attention to the winners (like Nephosity) and noting what they’re doing right.
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