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FDA Codifies Down-Classification For Devices Such As The Apple Watch ECG App

The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.

Regulation Policy

Eko Raises $65M In Series C Round To Expand AI-Based Digital Stethoscope For At-Home Patient Monitoring

Eko is banking on the growing telehealth market and reimbursement to expand its cardiac care platform.

Digital Health Financing

Fitbit Has OTC Electrocardiogram App To Rival Apple, Samsung With Clearance In US, EU

Fitbit will launch its new Fitbit Sense smartwatch with ECG app in Europe, US, Hong Kong and India in October. 

Approvals FDA

Fitbit Receives FDA Clearance, CE Mark For ECG App To Rival Apple

Fitbit will launch its new Fitbit Sense smartwatch with ECG app in Europe, US, Hong Kong and India in October. 

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