Fitbit launches new smartwatch as ECG awaits FDA approval

• Fitbit has launched a new smartwatch with multiple functions that help reduce stress levels and identify diseases. However, the wearable device maker is awaiting FDA approval for an important health trait.

Fitbit Sense, which includes a skin temperature sensor and heart rate tracking, intervenes when wearable devices are tested as early warning devices for COVID-19.

• The EKG app is currently under regulatory review in the United States and the European Union and will only be available pending approval, said a spokesperson who declined to comment at the time of approval.

Fitbit’s goal with the new watch, which will cost $ 329.95, is to track data such as electrodermal activity, stress signal and respiratory rate, blood oxygen, and heart rate variability with an EKG as the company focuses more on health management.

The new products represent “a transition from fitness tracking to an essential platform that puts you in control of your health,” CEO James Park said in a virtual launch recorded Monday. Google currently intends to acquire Fitbit for $ 2.1 billion.

Adding an EKG feature would update Fitbit with Apple and Samsung smartwatches that already have this feature. Apple devices have been offering heart rate monitoring since 2018.

Irregular heart rhythms or arrhythmias can indicate serious health problems. The purpose of the devices is to detect arrhythmias as early as possible so that the user can report the symptom to their physician. However, studies have shown known limitations to the effectiveness of heart rate monitoring devices, and industry experts have argued that anomalies reported by smartwatches should not be accepted as a diagnosis of concern that the false positives may lead to unintended medical intervention.

Significant renderings leaked with the latest version of the Versa line earlier this month. However, Fitbit has announced that it will work on the ECG feature in May. An in-depth study looked at whether its sensors could detect irregular heart rhythms, which could indicate atrial fibrillation, a major risk factor for stroke.

But getting the coveted green light from the FDA for an EKG is another matter. Fitbit has been working for years to obtain regulatory approval for the function of monitoring blood oxygen level (SpO2).

However, the San Francisco-based wearable device maker is a member of the FDA’s software precertification program, which aims to accelerate time-to-market for digital health products alongside Apple, Johnson & Johnson, and other big names in the field.

Manufacturers of wearable devices are also testing the effectiveness of their popular disease detection devices as consumer interest in home health management grows. Although wearable device shipments declined in 2020 as consumers cut back on nonessential purchases, Fitbit may want to capitalize on interest in the warning signs of COVID-19 and other illnesses.

Fitbit began investigating the effectiveness of its sensors in detecting COVID-19 in May. Although the study results have yet to be published in a peer-reviewed journal, a preprint published Wednesday found that Fitbit devices had detected nearly 50% of COVID-19 cases the day before the day participants started to experience symptoms.

A key metric was heart rate variability, which according to Fitbit data is the decrease in the number of COVID-19 positive patients while resting heart rate and respiration often increase.