Garmin expands ECG App to customers in Australia and the European Union
Garmin (NYSE: GRMN) has expanded its ECG App availability to customers in Australia and the European Union for compatible smartwatches, including Venu 3 Series and fēnix 8 Series. The app enables users to record 30-second ECGs and check for atrial fibrillation (AFib) signs directly from their smartwatch.
This marks Garmin's first smartwatch feature classified as a medical device in these regions. Users can view results immediately on their watch or through the Garmin Connect smartphone app, where they can also create shareable healthcare provider reports. The ECG App is specifically designed for adults aged 22 and over, functioning similarly to a Lead I ECG for detecting AFib or normal sinus rhythm.
The company plans to expand both its portfolio of ECG-compatible products and regional availability pending regulatory approvals. The feature requires the latest version of Garmin Connect app and smartwatch software.
Garmin (NYSE: GRMN) ha ampliato la disponibilità della sua app ECG per i clienti in Australia e nell'Unione Europea per smartwatch compatibili, inclusi Venu 3 Series e fēnix 8 Series. L'app consente agli utenti di registrare ECG di 30 secondi e controllare i segni di fibrillazione atriale (AFib) direttamente dal loro smartwatch.
Questa è la prima funzionalità per smartwatch di Garmin classificata come dispositivo medico in queste regioni. Gli utenti possono visualizzare i risultati immediatamente sul loro orologio o attraverso l'app Garmin Connect per smartphone, dove possono anche creare report condivisibili per i fornitori di assistenza sanitaria. L'app ECG è progettata specificamente per adulti di età pari o superiore a 22 anni, funzionando in modo simile a un ECG di Lead I per rilevare AFib o un ritmo sinusale normale.
La società prevede di ampliare sia il suo portfolio di prodotti compatibili con l'ECG che la disponibilità regionale in attesa di approvazioni normative. La funzionalità richiede l'ultima versione dell'app Garmin Connect e del software dello smartwatch.
Garmin (NYSE: GRMN) ha ampliado la disponibilidad de su aplicación ECG para clientes en Australia y la Unión Europea para relojes inteligentes compatibles, incluyendo la serie Venu 3 y la serie fēnix 8. La aplicación permite a los usuarios registrar ECG de 30 segundos y detectar signos de fibrilación auricular (AFib) directamente desde su reloj inteligente.
Esta marca la primera función para reloj inteligente de Garmin clasificada como dispositivo médico en estas regiones. Los usuarios pueden ver los resultados de inmediato en su reloj o a través de la aplicación Garmin Connect en sus smartphones, donde también pueden crear informes que se pueden compartir con proveedores de atención médica. La aplicación ECG está diseñada específicamente para adultos mayores de 22 años, funcionando de manera similar a un ECG de Lead I para detectar AFib o un ritmo sinusal normal.
La empresa planea ampliar su cartera de productos compatibles con ECG y la disponibilidad regional a la espera de aprobaciones regulatorias. Esta función requiere la última versión de la aplicación Garmin Connect y el software del reloj inteligente.
가민 (NYSE: GRMN)은 호주와 유럽 연합의 호환 가능한 스마트워치에 ECG 앱의 가용성을 확대했습니다. Venu 3 시리즈와 fēnix 8 시리즈를 포함합니다. 이 앱은 사용자가 30초 ECG를 기록하고 스마트워치에서 직접 심방세동(AFib) 징후를 확인할 수 있도록 합니다.
이는 가민이 이러한 지역에서 의료 기기로 분류된 최초의 스마트워치 기능을 제공하는 것입니다. 사용자는 자신의 시계에서 즉시 결과를 확인하거나 가민 커넥트 스마트폰 앱을 통해 결과를 확인할 수 있으며, 여기서 의료 제공자와 공유 가능한 보고서를 작성할 수 있습니다. ECG 앱은 22세 이상의 성인을 위해 특별히 설계되었으며, AFib 또는 정상 동성 리듬을 감지하기 위한 Lead I ECG와 유사한 방식으로 작동합니다.
회사는 규제 승인을 기다리면서 ECG 호환 제품의 포트폴리오와 지역 가용성을 확대할 계획입니다. 이 기능은 최신 버전의 가민 커넥트 앱과 스마트워치 소프트웨어를 필요로 합니다.
Garmin (NYSE: GRMN) a élargi la disponibilité de son application ECG pour les clients en Australie et dans l'Union Européenne pour les smartwatches compatibles, y compris la série Venu 3 et la série fēnix 8. L'application permet aux utilisateurs d'enregistrer des ECG de 30 secondes et de vérifier les signes de fibrillation auriculaire (AFib) directement depuis leur smartwatch.
C'est la première fonctionnalité de smartwatch de Garmin classée comme un dispositif médical dans ces régions. Les utilisateurs peuvent voir les résultats immédiatement sur leur montre ou via l'application Garmin Connect pour smartphone, où ils peuvent également créer des rapports partageables avec les prestataires de soins de santé. L'application ECG est spécifiquement conçue pour les adultes de 22 ans et plus, fonctionnant de manière similaire à un ECG Lead I pour détecter l'AFib ou un rythme sinusal normal.
L'entreprise prévoit d'élargir à la fois son portefeuille de produits compatibles ECG et la disponibilité régionale en attendant les approbations réglementaires. La fonctionnalité nécessite la dernière version de l'application Garmin Connect et du logiciel de smartwatch.
Garmin (NYSE: GRMN) hat die Verfügbarkeit seiner ECG-App für Kunden in Australien und der Europäischen Union auf kompatible Smartwatches, darunter die Venu 3 Serie und die fēnix 8 Serie, ausgeweitet. Die App ermöglicht es den Nutzern, 30-Sekunden-ECGs aufzuzeichnen und Anzeichen von Vorhofflimmern (AFib) direkt von ihrer Smartwatch aus zu überprüfen.
Dies ist die erste Smartwatch-Funktion von Garmin, die in diesen Regionen als medizinisches Gerät eingestuft wird. Nutzer können die Ergebnisse sofort auf ihrer Uhr oder über die Garmin Connect Smartphone-App einsehen, über die sie auch teilbare Berichte für Gesundheitsdienstleister erstellen können. Die ECG-App ist speziell für Erwachsene ab 22 Jahren konzipiert und funktioniert ähnlich wie ein Lead I ECG zur Erkennung von AFib oder einem normalen Sinusrhythmus.
Das Unternehmen plant, sowohl sein Portfolio an ECG-kompatiblen Produkten als auch die regionale Verfügbarkeit in Abhängigkeit von den regulatorischen Genehmigungen zu erweitern. Dieses Feature erfordert die neueste Version der Garmin Connect-App und der Smartwatch-Software.
- First Garmin smartwatch feature classified as a medical device in Australia and EU
- Expansion into new markets with medical-grade technology
- Integration with Garmin Connect app for comprehensive health tracking and reporting
- to users aged 22 and over
- Availability restricted to specific smartwatch models
- Requires regulatory approval for further market expansion
Insights
The expansion of Garmin's ECG App into Australia and the EU represents a strategic move in the digital health market. This regulatory clearance as a Class IIa medical device positions Garmin to compete directly with Apple and Samsung in the medical-grade wearable space. The timing is particularly advantageous as the global digital health market continues to expand, with ECG-capable devices projected to see substantial growth through 2025.
The ability to record ECGs on-demand addresses a critical gap in AFib detection, as traditional clinical monitoring often misses intermittent episodes. This feature's integration across multiple device lines, including the premium fēnix series, suggests a broader strategy to differentiate Garmin's offerings in the high-margin segment of the wearables market.
Market implications are significant - this expansion could drive increased adoption of Garmin's premium devices in healthcare-conscious demographics and potentially lead to partnerships with healthcare providers and insurers. The regulatory approval also creates barriers to entry for smaller competitors, strengthening Garmin's market position.
This product expansion aligns perfectly with the growing $8.3 billion global ECG devices market. The EU market, particularly, represents a substantial opportunity with its aging population and increased focus on preventive healthcare. Australia's addition, while smaller in scale, provides strategic value in the Asia-Pacific region.
The timing of this launch coincides with increasing consumer demand for health monitoring features in wearables, a trend accelerated by post-pandemic health awareness. Garmin's approach of making the feature available across multiple device lines maximizes market penetration potential and could drive upgrade cycles among existing users.
The medical device classification is particularly valuable for Garmin's market positioning, as it elevates the brand's credibility in the health monitoring space and justifies premium pricing. This could translate to higher ASPs and improved margins in these regions.
Customers can now record an ECG and check for signs of atrial fibrillation right from their compatible Garmin smartwatch
"The ECG App is Garmin's first smartwatch feature categorized as a medical device in
—Dan Bartel, Garmin Vice President of Global Consumer Sales
When customers take an ECG, the ECG App uses sensors on a compatible Garmin smartwatch 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, customers can view their history of ECG App results and create reports that can be shared with a healthcare provider.
Following the recent achievement of regulatory authorizations in the European Union and
Engineered on the inside for life on the outside, Garmin products have revolutionized the health and wellness industry. Committed to developing smart watches and health measurement tools that help people of all activity levels lead healthier lives, Garmin believes every day is an opportunity to innovate and a chance to beat yesterday. For more information, visit Garmin's virtual newsroom, email our press team, connect with @garminfitness on social media, or follow our adventures at garmin.com/blog.
1 | The ECG app is capable of recording an ECG similar to a Lead I ECG and detecting the presence of atrial fibrillation or normal sinus rhythm. The ECG app is only intended for adults aged 22 years and over. The ECG app is not intended to replace traditional methods of diagnosis or treatment. If atrial fibrillation is detected, consult a doctor. If you experience symptoms of a heart attack, stroke, or other cardiovascular conditions, do not rely on the notification of the device and consult a doctor. Always follow the instructions for use. The ECG app is not available in all regions and is only available on select Garmin smartwatches with the latest version of the Garmin Connect smartphone app and watch software. See Garmin.com/ECG for availability and full instructions for use. The ECG app is a Class IIa medical device under the EU Medical Device Regulation (MDR) (EU) 2017/745. |
2 |
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FAQ
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