Sign up for the QMED & MD+DI Daily newsletter.
January 25, 2023
1 Min Read
Image courtesy of Garmin/ PR Newswire
Garmin is the newest player to enter the ECG app market. The fitness wearables specialist said earlier this week that it received FDA clearance for the Garmin ECG App, which allows the user to record heart rhythm and check for signs of atrial fibrillation or normal sinus rhythm.
The app is available on the Venu 2 Plus smartwatch. When customers take an ECG, the ECG App uses sensors on the Venu 2 Plus to record the electrical signals that control how their heart beats. The ECG App then analyzes that recording to detect signs of AFib. Additionally, users have the option to sync their ECG App results to Garmin Connect. Through the Garmin Connect app, users can view their history of ECG App results and create reports that can be shared with a health care provider.
An email sent to a spokesperson for Garmin noted this was the company’s “first software medical device.”
The spokesperson added, “Garmin intends to continue to expand its portfolio of products supporting the ECG App and launch it in new regions in-line with necessary regulatory approval.”
There are a number of big tech companies with ECG apps. Already, Apple, Fitbit, and Samsung occupy the space. Apple led the charge winning FDA clearance for its ECG app in 2018.
Currently, the Cupertino, CA-based company is in litigation with AliveCor. Late last year, the International Trade Commission ruled that Apple infringed on Mountain View, CA-based AliveCor’s patents.
The ITC also issued a Limited Exclusion Order (LEO), a cease-and-desist order, and set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during the Presidential review period, potentially impacting sales of millions of infringing Apple Watches.
AliveCor initially sued Apple in December of 2020.
About the Author(s)
You May Also Like
Behind the Design of the Orchid Safety Release ValveFeb 27, 2024|4 Min Read
When Medical Device Design Had a Dimensional DilemmaFeb 27, 2024|2 Min Read
EU Council Endorse New Measures to Prevent Medical Device ShortagesFeb 27, 2024|2 Min Read
The Top 100 Medical Device CompaniesFeb 27, 2024|1 Min Read