Fitbit rolls out blood oxygen tracking with an eye toward FDA clearance for sleep apnea diagnosis feature

Fitbit devices include sleep tracking, and the wearables giant is now rolling out blood oxygen monitoring features that can be used to detect variations in breathing during sleep. (Fitbit)

Wearables giant Fitbit has rolled out a blood oxygen monitoring feature on some of its smartwatches, beating the Apple Watch on adding this functionality.

Fitbit, which Google agreed to buy in November, confirmed to FierceHealthcare that the company has activated a feature on its Charge 3, Ionic, Versa, Versa Lite and Versa 2 devices that provides users in the U.S. with blood oxygen data via the Fitbit app.

Users can see whether they are experiencing large variations in blood oxygen levels while they sleep.

The estimated oxygen variation graph provides users with an estimate of the variability of oxygen levels in their bloodstream, also referred to as SpO2. The data are derived from a combination of the red and infrared sensors on the back of the device, according to MaryEllen Green, a spokesperson for Fitbit.

RELATED: Fitbit expands healthcare ambitions with new devices, subscription service

The data shown in the graph are not a relative Sp02 estimate. "Being aware of variations in the oxygen levels in your bloodstream may indicate variations in your breathing during sleep. In general, variations should be low," Green said.

Apple holds patents for blood oxygen monitoring but has yet to activate the feature in any of its devices, according to CNET. Back in 2018, Garmin introduced Pulse Ox with its Vivosmart 4 activity tracker, allowing users to gauge their blood oxygen saturation levels on the spot or periodically as they sleep, CNET reported. 

Health tech company Withings recently unveiled its new ScanWatch, which also has similar monitoring capabilities. However, it is still undergoing FDA clearance, according to CNET.

Fitbit's end goal is to secure Food and Drug Administration (FDA) clearance for a sleep apnea diagnosis feature.

"Fitbit continues to collect clinical data to test and develop FDA cleared features for sleep apnea. We expect to submit for FDA clearance soon. We continue to maintain a dialogue with FDA throughout this process," Green said on behalf of Fitbit.

RELATED: Fitbit collaborating with pharma giants Bristol-Myers Squibb and Pfizer

Fitbit president and co-founder James Park said during the company's second-quarter 2019 earnings call: "In terms of the FDA, we're continuing to work with the FDA on a variety of initiatives, including around sleep apnea." He added during the call that he couldn't give a time frame on FDA clearance.

The wearables giant also plans to submit atrial fibrillation detection software to the FDA for regulatory review and approval, the company said in October.

Fitbit and pharmaceutical giants Bristol-Myers Squibb and Pfizer inked a multiyear partnership to accelerate the detection and diagnosis of atrial fibrillation to reduce the risk of life-threatening events such as stroke.

RELATED: Heating up competition with Apple in the smartwatch space, Google acquires Fitbit for $2.1B

Once its afib detection software receives FDA clearance, Fitbit will work with the BMS-Pfizer Alliance to provide those who are alerted by the wearable device of a potential heart rhythm irregularity with appropriate information to help encourage and inform discussions with their physicians, the companies said in October.

Fitbit is expanding its healthcare ambitions. And a new study published in the Lancet Digital Health journal found that heart rate and sleep data from wearable fitness tracker watches can predict and alert public health officials to real-time outbreaks of flu more accurately than current surveillance methods.

The study used data from more than 47,000 Fitbit users in five U.S. states. By using the data, statewide predictions of flu outbreaks were improved and accelerated, the study said.

Industry analysts see Google's $2.1 billion acquisition of Fitbit as a data play as Fitbit's devices now collect data—such as the number of steps taken, sleep duration, menstrual cycles and heart rate—from 27.3 million users. 

The deal, expected to close this year, faces scrutiny from the Justice Department for possible antitrust issues, according to multiple media reports.

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