Google Seeks FDA Nod For Fitbit’s Passive Heart Rate Monitoring Tech Google Seeks FDA Nod For Fitbit’s Passive Heart Rate Monitoring Tech

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Fitbit passive heart rate FDA approval


Fitbit passive heart rate FDA approval
Photo credit: Fitbit

Fitbit’s parent company Google is seeking US Food and Drug Administration (FDA) approval for Fitbit’s passive heart rate monitoring algorithm.

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The technology was built using data collected from a study of US Fitbit users launched in May 2020. The Fitbit Heart Study aimed to detect atrial fibrillation (AFib), also known as irregular heart rhythm.

AFib is common in the US, affecting around 12.1 million people, with advancing age, high blood pressure and obesity all common risk factors for the condition. One out of every four people will experience AFib at some point in their lifetime.

Currently, Fitbit can only periodically check for irregular heart rhythm; Fitbit users must decide to check it. Fitbit’s new feature, however, could run in the background and notify people if they’re exhibiting symptoms of atrial fibrillation. This would help Fitbit better compete with the Apple Watch’s EKG feature, which also checks heart rhythms and alerts users of irregularities.

A smartwatch showing heart rate
Photo: Fitbit

Fitbit launched a study in 2020 to test its passive heart rhythm technology. Nearly half a million Fitbit users participated in the study, and it flagged around 1 percent of participants (just under 5,000 people) as having an irregular heart rhythm, according to data presented at the 2021 American Heart Association meeting. Those people were asked to set up a telehealth consultation so they could get an EKG patch, and around 1,000 did so. Of that group, a third had the diagnosis confirmed — giving the tech a positive predictive value for atrial fibrillation of 98 percent, reports The Verge.

“These results are extremely promising and we think will have a real impact on early detection and treatment of this important condition,” Tony Faranesh, a research scientist at Fitbit, said in a press briefing.

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Post-FDA approval, Fitbit devices will come closer to the Apple Watch in terms of passive heart monitoring capabilities and give it the much-needed ability to send out a warning in the event of atrial fibrillation.



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