Dive Brief:

• Fitbit and two major pharmas announced Thursday they are working together to develop educational content for individuals at increased risk for atrial fibrillation, with the aim of speeding earlier diagnosis of the condition and the associated risk of stroke.
• The partnership between the Bristol-Myers Squibb-Pfizer Alliance and the wearables maker comes amid ongoing development of AFib detection software for several Fitbit devices. The pharmas are not directly involved with its development.
• Amy McDonough, general manager of Fitbit Health Solutions, told MedTech Dive the company does not have a publicly announced timeline for FDA submission of the AFib software or its sleep apnea software also in development.

Dive Insight:

While details on the new partnership remain slim, the two drugmakers manufacture Eliquis, an anticoagulation treatment indicated for the prevention of stroke in individuals with atrial fibrillation approved in 2012.

"We believe we can develop content to help bridge the gaps that exist in atrial fibrillation detection, encouraging people to visit their doctor for a prompt diagnosis and potentially reduce their risk of stroke," Fitbit CEO James Park said in a statement.

Sales of Eliquis, which competes primarily with Bayer and Johnson & Johnson's Xarelto, reached nearly $4 billion over the first six months of 2019. Bristol-Myers and Pfizer roughly split profits globally.

"What we'll be doing is combining resources and areas of expertise to help identify and support people who are at increased risk for AFib," McDonough said. "Those at age 65-plus are particularly at risk."

The effort to bring AFib detection to its devices and more deeply integrate into the healthcare ecosystem comes as Fitbit faces mounting competitive pressures to its fitness tracker business from Apple, Google, LG and Samsung.

"Smartwatches with health and fitness functionalities may displace the market for traditional tracker devices," a recent Fitbit SEC filing said. "For example, Apple's recently introduced Apple Watch includes electrocardiogram functionality and fall detection capability."

In recent months, Fitbit entered discussions with investment bank Qatalyst Partners over potentially selling due to its financial challenges competition in the crowded smartwatch market, Reuters reported in September.

Fitbit is a pilot participant in FDA's Software Precertification Program alongside companies including Johnson & Johnson, Apple and Samsung. FDA is evaluating if it can scrutinize companies rather than individual software product iterations to speed incremental updates to market. It is unclear if Fitbit will seek to utilize the pilot pathway for its submission of its AFib software.

"Since we're still in the submission planning stages, we'll evaluate all of those opportunities, but we haven't disclosed that," McDonough said.

Fitbit products Inspire HR, Alta HR, Charge 2, Charge 3, Versa, Versa Lite, Versa 2 and Ionic, which have an optical heart rate monitor in the device, will have access to the AFib software if FDA eventually grants it clearance, according to a Fitbit spokesperson.

This story has been updated with the correct approval date for Eliquis.