Indiegogo Project uChek Will Have To Seek FDA Approval

uchek-urine-appThe fast-and-loose world of crowdfunding and tech is sometimes a little too fast and loose for certain regulatory agencies. Add the FDA to that list. The agency recently put the heat on Biosense for not obtaining FDA approval for the uChek.

The uChek is currently crowdfunding on Indiegogo. The “medical lab in your phone” promises to provide backers a smartphone app that allows at-home urine analysis. The campaign has five days left and is well short of a stated $42,000 goal on fixed funding.

Bloomberg is reporting that the FDA has sent a letter to India-based Biosense, the company behind the uChek, taking issue with their lack of FDA clearance.

“There’s a gigantic gulf between the tech industry as a whole and the medical regulatory infrastructure,” David Jones, chairman and managing director of venture capital company Chrysalis Ventures, said in an interview.

Apps like uCheck are subject to a light version of FDA approval that requires product creators to prove that their products are similar to a product already on the market. This allows these types of products to skip the costly and time-consuming clinical trial process.

Biosense has clarified that they have stopped selling the uChek in the US and plan to seek FDA approval.


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