Fitbit Archives - Medical Design Sourcing

How Dexcom uses wearables to deliver differentiated diabetes management

Dexcom has worked with Garmin to create apps on Garmin devices that use real-time CGM data. [Image from Garmin]Dexcom (Nasdaq:DXCM) is one of the leaders in the diabetes technology space with its continuous glucose monitoring (CGM) technology.

The company’s current-generation Dexcom G6 CGM remains one of the biggest players in the CGM space. Meanwhile, its next-generation Dexcom G7 CGM has already launched in a number of countries overseas. The wearable device — which features a 60% size reduction from G6 — still awaits FDA clearance.

Dexcom sits among a number of companies developing wearables for helping people manage their diabetes. The company’s SVP for Product, Global Marketing, Apurv Kamath, spoke today at AdvaMed’s The MedTech Conference on the impact of wearables.

While he focuses on diabetes management, the panel on which he sat covered a range of uses for wearables in medtech. It featured Alissa Hsu Lynch, global lead for medtech…

Google, Fitbit unveil smartwatch that can detect AFib

[Image from Google/Fitbit]Google today unveiled its first full-featured premium smartwatch developed with Fitbit’s health and fitness expertise.

In August, Google unveiled its new Fall lineup that included The Fitbit Sense 2. Google said at the time that it marks the company’s “most advanced health-focused smartwatch.” It features more than six days of battery life. The watch aims to help users manage stress and track heart health through sensors that can detect signs of AFib, among other things.

Google’s latest announcement features the Google Pixel Watch as part of the fall product line. The company called it a “natural extension” of the Pixel family in a blog post. It said the watch combines “smarts and helpfulness” with Fitbit’s health and fitness expertise.

Features include water resistance and scratch resistance with a design meant for wearing all day and night.

The watc…

Fitbit unveils fall lineup that includes AFib-detecting smartwatch

[Image from Google/Fitbit]Google’s Fitbit has announced its upcoming releases this fall, with one health-focused offering providing heart health tracking capabilities.

According to a blog post presenting the new offerings, the new Inspire 3, Versa 4 and Sense 2 — the latter of which being the heart health tracker — are all thinner and more comfortable than previous versions, offering all-day wearability and no need to charge the devices every day.

The Fitbit Sense 2 marks the company’s “most advanced health-focused smartwatch,” according to the post. It features more than six days of battery life to help users manage stress and track heart health through sensors that can detect signs of AFib, among other things.

The device marks Fitbit’s bid to better compete against the heart monitoring tech on the Apple Watch, which is FDA-cleared for irregular heart rhythm detection and notification.

Fitbit said that through its ECG a…

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…

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…

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…