Core Message - Garmin has launched an ECG App for compatible smartwatches in Australia and the European Union, enabling users to record heart rhythms and detect signs of atrial fibrillation (AFib) [1][2][3] Product Features - The ECG App allows users to record a 30-second ECG and view results immediately on the watch or via the Garmin Connect smartphone app [1] - The app uses sensors on compatible Garmin smartwatches to record electrical signals and analyze them for AFib signs [3] - Users can sync ECG results to Garmin Connect, view historical data, and create reports to share with healthcare providers [3] Regulatory and Availability - The ECG App is classified as a Class IIa medical device under the EU Medical Device Regulation (MDR) (EU) 2017/745 [6] - It is currently available in Australia and the European Union, with plans to expand to other regions pending regulatory approvals [4] - The app is compatible with select Garmin smartwatches, including the Venu 3 Series and fēnix 8 Series [1][6] Company Strategy - Garmin aims to continue expanding its portfolio of products supporting the ECG App and launching it in new regions [4] - The company emphasizes innovation in health and wellness, focusing on developing tools that help users lead healthier lives [5] Product Limitations - The ECG App is intended for adults aged 22 and over and is not a replacement for traditional diagnosis or treatment methods [6] - Users experiencing symptoms of serious cardiovascular conditions are advised to consult a doctor rather than relying solely on the device [6]
Garmin expands ECG App to customers in Australia and the European Union