Fitbit receives FDA clearance for ECG app

Fitbit received regulatory approval in the US and Europe for its new ECG app to monitor heart rate and report signs of atrial fibrillation.

• Regulatory go-ahead updates Fitbit with other manufacturers such as Apple and Samsung, which have been offering ECG monitoring on their smartwatches since 2018 and early August this year, respectively.

• This is an important feature for the Fitbit Sense smartwatch released in late August. The app will be available in the US in October and in some countries in Europe and Asia.

Fitbit, which Google is currently looking to acquire for $ 2.1 billion, has left device makers behind to compete with product development and approval in the heart rate monitoring space. However, word got out with Monday’s announcement that the San Francisco laptop giant received 510 (k) clearance from the FDA and CE mark in the European Union.

Atrial fibrillation or rapid or irregular heart rate causes poor blood flow and can lead to blood clots, strokes, heart failure, or other heart complications. It affects approximately 33.5 million people worldwide, but it is visibly difficult to detect. Apparel companies are testing and covering approvals for their devices as early warning alarms for signs of atrial fibrillation, supported by the industry shift toward remote monitoring and home care. The hope is that patients will play a more proactive role in their health and, as the data knows, report potential symptoms to their doctors.

But any evidence that wearable devices change people’s daily health, fitness, and healthy behaviors are incomplete. Industry insiders, concerned that false positives could lead to unnecessary medical interventions, say that abnormalities reported by smartwatches should not be accepted as a diagnosis. And studies have shown limitations in the devices’ ability to effectively control heart rate.

Fitbit conducted a multi-site clinical study in the United States to evaluate the accuracy of its algorithm in detecting atrial fibrillation based on normal sinus rhythm and generating an ECG exchange or recording an electric heart as part of the regulatory process.

The study showed that the algorithm exceeded the performance target and had 98.7% of cases of atrial fibrillation. It’s also 100 percent accurate at identifying people with normal sinus rhythms, Fitbit said.

The 13-year-old manufacturer began a heart transplant study in May this year with the aim of showcasing photoplethysmography (PPG) technology to detect abnormal heart rate which may be a symptom of Afib. The PPG monitors small changes in blood volume in the pulse as the heartbeats. Fitbit hopes that the results of the study, which involved more than 400,000 participants in four months, will improve regulatory documents for the long-term functionality of heart rate devices.

Fitbit recently tried to reposition itself as a health and wellness operator and move away from its roots as a manufacturer of fitness tracking devices. The $ 329.95 Sense device is the first Fitbit to have an ECG.

The company is also investigating whether its devices are effective in diagnosing COVID-19 symptoms early as new cases continue to emerge in the United States and continue to be investigated. The results of the study, which began in May, have yet to be published. However, a preprint released in August contains Fitbit sensors, which reported nearly half of COVID-19 infections the day before symptoms began.