In Las Vegas: A Tale of Two Devices at CES
The FDA's job may need clarification as technology changes. Fitness devices are becoming more intelligent and will soon produce data that approaches medical advice.
Scanadu's Scout Device
Two years ago, at the end of my on-site roundup of the building digital health excitement at the International CES show, I wrote about Scanadu, a company developing a noninvasive vital sign reader called the Scout. At the time, Scanadu's founders showed their prototype at a table at one of the off-floor CES press events. It was to my knowledge one of the only announced products at the show waiting for FDA clearance before going on sale.
Today, two years later, Scanadu still doesn't have FDA clearance, and you can't buy the Scout on the company's website. It's a shame, really. The product is more elegantly designed than many consumer electronics products, appears to be simple to use, and provides a lot of valuable biometric information to someone possessing one.
But here is where we get into what's wrong with CES, or what's wrong with the FDA, or perhaps both.
The digital health section of CES is substantially larger than it was two years ago, but few if any devices on display are FDA-approved, and thus have everything to do with fitness and virtually nothing to do with health monitoring. This is by design, a grand bargain FDA reached with industry many years ago, which I studied at length in 2013 when I earned a certificate in clinical trial design and management at the University of California San Diego Extension.
Devices that purport to treat disease must get the FDA's blessing. Devices that simply provide information but do not claim to treat disease may proceed without FDA approval, but must warn users they are not designed to treat disease.