US Food and Drug Administration intends to have tighter rules for apps that allow to diagnose or treat medical conditions, similar to the 2011 proposal urging for quality standards for ultrasound machines, heart stents, and several other medical equipment.
The FDA plans to finalise the guidance by this year, reproted Bloomberg, citing the agency spokewoman.
It has proposed a regulatory approach that restricts its immediate oversight to a particular set of mobile medical applications that act as medical devices and can present greater risk to patient safety in case they do not work as required.
iPhone applications allows users to check levels of blood, and other substances in their urine. And as the industry for medical diagnosis on-the-go is rapidly growing, the US regulators plan to have tighter rules.
Meanwhile, India-based Biosense told Bloomberg that it intends to work on uChek system with the agency in the next few months in order to roll out affordable and precise diagnostic device into the market.
This system allows users such as diabetics to check their glucose levels by dipping the test strips in urine, following which smartphone’s camera enables the system to quickly process and produce automated results.
uChek system works with only test strips that are manufactured by Siemens and Bayer, which have received FDA clearance for visual reading, but need further approval for automated analysis.