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Fitbit Receives FDA Clearance for ECG App



Dive brief:

  • Fitbit has received regulatory approval in the United States and Europe for its new EKG app to track heart rate and report signs of atrial fibrillation.
  • The regulatory nod brings Fitbit up to date with other manufacturers like Apple and Samsung, which have been offering ECG tracking in their smartwatches since 2018 and early August of this year, respectively.
  • This is a key feature for the Fitbit Sense smartwatch, which launched in late August. The app will be available for the watch in October in the US and select countries in Europe and Asia.

Dive overview:

Fitbit, which Google is currently seeking to acquire For $ 2.1 billion, device makers lagged behind competitors in the development and approval of heart rate monitoring products. But the playing field has stabilized with Monday announcement the San Francisco-based wearable giant had received 510 (k) clearance from the FDA and CE marked in the European Union.

Atrial fibrillation, or irregular or rapid heart rate, causes poor circulation and can lead to blood clots, stroke, heart failure, or other heart complications. It affects some 33.5 million people worldwide, but is particularly difficult to detect. Wearable device companies have tested and obtained approvals for their devices as early warning detectors for signs of AFib, bolstered by the industry-wide move to remote monitoring and healthcare. home health. The hope is that patients will take a more proactive role with their health and, informed by the data, report potential symptoms to their doctors.

But any evidence that wearable devices are causing people to change their daily health, fitness and wellness behaviors is patchy. Experts in the field fear that false positives could lead to unnecessary medical interventions, argued any anomalies reported by smartwatches should not be accepted as a diagnosis. And studies have shown limitations around device capacity to effectively monitor heart rate.

Fitbit conducted a multi-site clinical trial in the United States to assess the accuracy of its algorithm in detecting atrial fibrillation from a normal sinus rhythm and generating an ECG exchange, or rhythm recording. electrical heart, as part of the approval process.

The study showed that the algorithm exceeded target performance, detecting 98.7% of atrial fibrillation cases. It was also 100% accurate in identifying people with normal sinus rhythm, Fitbit said.

The 13-year-old maker also launched a heart rate study in May this year in an effort to validate its photoplethysmography (PPG) technology to find irregular heart rhythms that could be signs of Afib. PPG monitors tiny fluctuations in blood volume in the wrist as the heart beats. Fitbit hopes the results of the study, which recruited more than 400,000 participants in about four months, will strengthen its regulatory submissions for its long-term heart rate device functionality.

Fitbit recently tried to reposition itself more as an operator focused on health and wellness, moving away from its roots as a manufacturer of fitness tracking devices. The $ 329.95 Sense device is Fitbit’s first with an ECG.

The company is also studying whether its devices are effective in detecting early symptoms of COVID-19, as new cases continue to increase in the United States. The results of the study launched in May have not yet been published, but a preprint released in August maintains that Fitbit sensors reported nearly half of COVID-19 infections a day before participants noticed symptoms.

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