FDA clears Fitbit PPG algorithm to detect AFib

Fitbit (NYSE:FIT) today announced it received FDA clearance for its photoplethysmography algorithm to identify atrial fibrillation.

The consumer electronics company designed the photoplethysmography (PPG) algorithm to passively assess heart rhythm when the user is still or sleeping. It allows users to proactively screen for AFib and records an electrocardiogram trace to allow for long-term heart rhythm assessment. If the Fitbit algorithm detects a heart rhythm indicative of AFib, the user will be notified through the company’s irregular heart rhythm notifications feature and can be reviewed by a healthcare provider.

AFib affects nearly 33.5 million people across the world, according to the National Institutes of Health. It can be difficult to detect as patients often have no visible symptoms of the heart condition.

Fitbit’s algorithm is supported by data from a landmark Fitbit Heart Study that was launched in 2020 and enrolled 455,699 partici…

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Fitbit wins U.S., EU regulatory approval for ECG app

Fitbit (NYSE:FIT) announced today that it received FDA 510(k) and CE Mark clearance for its electrocardiogram (ECG) app.

San Francisco-based Fitbit’s ECG app is designed to assess heart rhythm for atrial fibrillation (AFib), offering a simple method for on-the-spot readings, including whenever a user notices any unusual cardiac symptoms, according to a news release.

The Fitbit Sense wearable smartwatch is the company’s first device compatible with the ECG app, allowing users to hold their fingers to the stainless steel ring on the watch while holding still for 30 seconds to get a reading that can then be shared with a doctor.

With an on-wrist skin temperature sensor, an electrodermal activity sensor for managing stress and six or more days of batter life, the device is designed to help users control wellbeing on multiple fronts.

As part of its regulatory submission process, Fitbit conducted a multi-site clinical trial across the U.S. w…

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NASA, Fitbit gain EUAs for COVID-19 devices

The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT).

According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to garner EUA status.

NASA’s VITAL compressor is designed to offer continuous ventilatory support for adult patients requiring ventilation when no standard ventilators are available. It is a restricted device intended for use by a qualified healthcare provider.

The VITAL compressor is the second NASA ventilator to earn EUA, after the original VITAL device obtained authorization last month. NASA touts VITAL as capable of being built faster and maintained more easily than a traditional ventilator. The device includes fewer parts than other ventilators, many of whi…

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