Bloomberg reports that the FDA on May 22 sent a letter to the makers of a biomedical iPhone application named uChek. The app, when accompanied with a separate test strip kit, helps users to perform a self-urinalysis and subsequently monitor a number of health indicators such as protein and glucose levels. These test results can help provide insight into the status of "carbohydrate metabolism, kidney and liver function, acid-base balance and bacteria."
Back in February, we reported:
The product works by leveraging the iPhone's highly sensitive camera to read tints from inexpensive urine dip stick tests. Developed by Mumbai-based Myshkin Ingawale, an MIT grad, the app shifts monitoring away from expensive clinics and into the home.
The app was put on the market by Ingawale's startup, a company called Biosense, and works by using the iPhone's camera to analyze test strips normally designed for visual assessment. On iTunes, the company indicates that the app should only be used with the recommendation of a qualified healthcare professional. That apparently isn't enough for the FDA.
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 Food and Drug Administration 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.
Under the FDA's current proposal, the agency would wield some regulatory and approval power over a select number of mobile apps that pose the most risk to consumers in the likelihood of an app not working as intended.
Official guidance on the extent of the FDA's role in the approval of medical apps will be finalized later this year, according to FDA spokeswoman Synim Rivers.
Biosense, meanwhile, has indicated that it is open to working with the FDA "to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world."
In the meantime, the FDA will wait and see how Biosense responds to its inquiry. Following that, Rivers explained the agency may issue a "warning letter that sets out specific violations of the law must be addressed immediately."
You can check out more information as to how the app works over here on uChek's website.