medical app regulation

By Aditi Pai 12:35 pm March 1, 2016
About five months after the Federal Trade Commission (FTC) first charged the marketers of a vision improvement app, called UltimEyes, with deceptively claiming their program was scientifically proven to improve the user's eye sight, the FTC has approved a final consent order that requires the company to stop making these claims. Carrot Neurotechnology, the company behind the UltimEyes, charges $9...
By Brian Dolan 11:48 am September 21, 2015
The Federal Trade Commission (FTC) has charged the marketers of a vision improvement app, called UltimEyes, with deceptively claiming they their program was scientifically proven to improve the user's eye sight. The company behind the app, Carrot Neurotechnology, and its co-owners Adam Goldberg and Aaron Seitz have agreed to pay $150,000 and to stop citing the claims. Notably, the $5.99 app is...
By Jonah Comstock 09:37 am May 5, 2015
The Mersey Burns app is mentioned by name in the RCP guidelines. The Royal College of Physicians of London, the professional organization that sets the standards of medical training in the UK, has published a set of guidelines about how doctors there should use medical apps. The two-page guidance document places a heavy emphasis on the CE Mark, but also places the onus on doctors to use their...
By Brian Dolan 05:39 am January 16, 2015
As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days. "A general...