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What is LifeLens Wireless ECG Monitor Approval about?

The FDA has determined that the LifeLens Wireless ECG Monitor is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under Class II regulations. The device is intended for patients experiencing transient symptoms and includes a disposable skin adhesive component, a reusable hub, and a gateway for data management. Testing demonstrated no new risks and confirmed the device

Author

劉雅淇

Language

EN