Some of the world's most valuable technology companies are moving into the regulated medical sector. And now they have found an important ally from within the federal government.
The U.S. Food and Drug Administration this week said that it will work with nine companies — including Alphabet, Apple, Fitbit and Samsung — to make it easier to fast-track medical software that is deemed to be of low risk through the regulatory approval process. The program is known as the "precertification pilot."
What that means, according to regulatory experts, is that these companies are moving from wellness (fitness, nutrition and so on) and into the medical market. In other words, if the program proves successful, the Fitbit and Apple Watch of the future won't simply track step counts, but also screen for medical conditions so users can seek medical help before it's too late.
Of course, that will require a lot of clinical studies to prove that these tools are both accurate and sensitive. And the companies still need to figure out whether they'll target a general population, or only those at high risk for a disease.
CNBC reported this month that Apple is teaming up with Stanford to study whether the Apple Watch can detect a heart rhythm disorder called atrial fibrillation. Apple is also working on other novel medical sensors for its devices, CNBC reported, including technologies to track blood glucose.
Apple rival Fitbit is also looking at some of these areas, with an initial focus on both atrial fibrillation and a medical condition called sleep apnea. In both cases, it's not yet clear if these companies will claim to "screen for" or actually "diagnose" disease — a subtle difference, but not a trivial one.
Regulatory experts say that the participation of these tech companies in the pilot program suggests that health is a priority, rather than a temporary fascination. "There's no point in doing this for one product," said Bradley Merrill Thompson, an FDA specialist with the law firm Epstein Becker & Green.
It makes sense to get involved, he said, for companies that intend to be in it for the long term. "That's apparently where these companies see themselves," Thompson added.
Here is the full list of companies in the program:
- Johnson & Johnson
- Pear Therapeutics