Fitbit Awaiting Regulatory OKs on ECG App for Its Most Advanced Health Smartwatch

Fitbit is taking preorders for two smartwatches and a tracker slated for late September availability, including the Sense ($329), billing it as its most advanced health smartwatch. The Sense has an electrodermal activity sensor for stress management, an on-wrist-based skin temperature sensor and an electrocardiogram (ECG) app. When used with Fitbit Premium ($9.99 monthly), the watch can help track heart rate variability, breathing rate, and oxygen saturation using the company’s Health Metrics dashboard, said the company Tuesday.

Pending regulatory approvals show the challenging route to digital health solutions for consumer tech companies. The ECG app, not intended for use by people under 22, will be available in the U.S. based on FDA clearance. It hasn’t received a CE mark and “will not be marketed, put into service or made available in the European Union until it receives regulatory approval,” Fitbit said.

The Sense’s EDA sensor measures electrodermal activity responses; users place their palm over the watch face to detect small electrical changes in the sweat level of the skin. Measuring EDA responses can help them understand the body’s response to stressors and help manage it, it said. A stress management score calculates how the body is responding to stress based on heart rate, sleep and activity data.

Sense is Fitbit’s first device with an ECG app to assess heart rhythm for signs of atrial fibrillation. Users hold their fingers on the corners of the watch ring, while being still for 30 seconds, to receive a reading that can be downloaded to share with a doctor, the company said. They can also get on-device high and low heart rate notifications via Fitbit's new PurePulse 2.0 technology.

Results from a COVID-19 study of 100,000 Fitbit users suggested that changes in some metrics included in the new dashboard in the company’s Premium subscription service -- breathing rate, resting heart rate and heart rate variability -- can be detected by Fitbit devices simultaneously with the onset of COVID-19 symptoms, “and in some cases even before,” it said. Wearables “may be able to play an important role in the early detection of infectious diseases by acting as an early warning system for our bodies, which is critical to slowing the spread of COVID-19 and to better understanding disease progression,” said Chief Technology Officer Eric Friedman. “Our algorithm can detect nearly 50 percent of COVID-19 cases a day before the onset of symptoms with 70 percent specificity." The research could help detect other diseases in the future, he said.

Fitbit also unveiled the Versa 3 smartwatch ($229) with GPS and Google Assistant. Google announced it was buying Fitbit in November. The EC voiced concern over the proposed acquisition, saying it would further entrench Google’s market position (see 2008040050). Google said the buy was about devices, not data. Versa 3 also has Amazon Alexa voice control, a built-in speaker and mic “to take quick phone calls, send calls to voicemail and adjust call volume,” said the company. Also coming is the Inspire 2 tracker ($99) with a brighter screen, heart-rate tracking and 10-day battery life.