We live in a remarkable time in which technology is advancing so rapidly that we cannot foresee all the implications of new devices as they appear. Who could have imagined that personal computers would lead to the “mining” of digital currency? Or that inexpensive electronics would result in cars that can drive themselves on standard roads? For me, one of the marvels is the fact that the smartphone — that has become so commonplace in our lives — has also become a medical device. Not only are there apps and add-ons that help us track our activity and give us information on our health, but there now are apps that can be used for diagnosis and treatment of chronic conditions and disease.
For example, Cognoa is a company that has developed an AI-based system for diagnosing behavioral health issues in children. The technology was initially developed at Harvard and Stanford, and is based on five years of clinical research. The average age for an autism diagnosis is just over 4 years old, but treatment can be much more effective if started much earlier than that. The Cognoa system has been clinically validated to work with children as young as 18 months old. A smartphone app lets parents report on various aspects of their child’s natural behavior at home. The system can then recommend personalized interventions that parents can do at home. This approach helps give parents confidence about whether or not their child is developing with normal expectations, and if not, gives them a path to help treat the problems.
The big news is that this smartphone app and the supporting system has been cleared by the FDA as a Class II diagnostic medical device for autism. This could mean that more children will receive developmental screening at an earlier age, and conditions such as autism will be identified earlier. Treatment should be more effective when started sooner, and in turn this will improve the quality of life and save on long-term healthcare costs. And this is possible simply because someone realized that we’d like to have a battery-powered phone in our pocket that we could use to make and receive phone calls anywhere.
Hello. I don’t see this on the FDA website. Could you help me to find ?
Thx
My best suggestion is to contact the company and see if they can direct you to a source at the FDA. I expect that they will have it readily at hand.
All the best,
Alfred Poor, Editor