Dive Brief:
- Fitbit on Thursday said it will begin rolling out its latest wearable fitness tracking device, the Charge 3, on Sunday and will go live with a beta version of its Fitbit Labs Sleep Score program in November.
- Participants accepted to the program will be able to track breathing disruptions that could signal health problems. Fitbit said that in addition to the sleep score program, it is conducting clinical research aimed at validating its software for use in detecting health conditions such as sleep apnea and atrial fibrillation.
- The San Francisco-based company said pre-orders for the Charge 3, which will cost $149.95, are exceeding those for its earlier-generation Versa device in the first six weeks.
Dive Insight:
Data from the Fitbit devices with a relative SpO2 sensor will inform its Fitbit Labs Sleep Score beta program, which will be available for a limited time to qualifying Fitbit users in the United States, Australia and United Kingdom.
"Data from this sensor will feed into the upcoming launch of our Fitbit Labs Sleep Score beta, which will allow users to better understand metrics like their sleep quality and breathing disturbances. In the future, with FDA approval, this data could be used to screen and detect more serious health conditions, such as sleep apnea," Fitbit CEO James Park said in a statement.
With digital health applications from such names as Apple, Fitbit and Johnson & Johnson making inroads into the medical device space, FDA is moving quickly to develop a software precertification program to address products at the intersection of both worlds.
Fitbit is one of nine companies in FDA's digital health software precertification pilot program for Software as a Medical Device.
The program could replace the need for a premarket submission for certain medical software products and allow for a streamlined review of marketing submissions for others. Manufacturers eligible for the new regulatory framework have shown "a robust culture of quality and organizational excellence," according to FDA.
"Because of software's faster iterative design, development, and validation, traditional implementation of the premarket requirements may impede or delay patient access to advances in software technology that would improve public health," FDA has said.
The new Charge 3 device features updated health and fitness sensors and algorithms, a large touchscreen display and up to seven days of battery life. It is also waterproof.
Fitbit said 54% of pre-orders on Fitbit.com have come from customers who previously owned two or more of its devices before ordering Charge 3.
