Posts Tagged ‘Federal Trade Commission’
Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews): The digital health ecosystem has swelled to encompass a broad range of products over the years. On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA…
Read MoreBrain training franchisor LearningRx settles FTC complaint about its marketing claims
LearningRx To Pay $200K For Allegedly Unproven Claims That Brain Training Can Improve Income, Treat Autism & ADHD (Consumerist): “The company behind the LearningRX “brain training” program has agreed to pay a $200,000 settlement and to stop making claims that its system is clinically proven to treat serious health conditions, or that it can
Read MoreUnder new CEO, Lumosity to expand brain training platform with focus on applied skills and broader social, wellness factors
Lumosity’s Stumble Reveals How We Think About Thinking (BuzzFeed News): “The ads were pervasive, popping up on CNN, Fox News, NPR, and Google searches. And they were persuasive: Playing Lumosity games would do your brain good…But these claims sounded a little too rosy to the Federal Trade Commission, which
Read MoreImportant conversation: Who knows more about improving vision, a) the Federal Trade Commission or b) 60+ vision scientists
FTC Action Risks Stifling Innovation, Health App Inventor Says (Bloomberg): “Federal enforcement action against the makers of a mobile app that claims to improve users’ vision will have a chilling effect on scientists hoping to commercialize their research, the app’s inventor told Bloomberg BNA Feb. 24.
Read MoreThe Federal Trade Commission vs Lumosity: What does it mean for the brain training market?
___ Despite all the noise around brain training, we must be careful not to confuse commerce with science. It is important to remember that the Federal Trade Commission (FTC), which regulates marketing claims and communications in the United States, issues legal rulings against specific commercial behaviors.
Read MoreNext: How to best civilize the mobile brain health and brain training Wild West (Tip: Consumer education may help more than pure regulation)
UC Riverside Professor Slams Feds, Stands By His Health App (KQED): “UC Riverside professor of psychology Aaron Seitz had an idea for a mobile health app based on his area of research.…Seitz is the academic behind UltimEyes, the vision improvement app that got dinged by the Federal Trade Commission (FTC) for $150,000 last week for making deceptive…
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