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Medical Devices / Submissions and Approvals

Cardiologs Technologies’ ECG Analysis Platform Scores 510(k) Approval

July 11, 2017
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The FDA has awarded 510(k) approval to Cardiologs Technologies’ ECG analysis platform.

The platform uses cloud-based cardiac monitoring and analysis web service to analyze long-term ambulatory ECG monitoring recordings. The system has already secured the CE Mark in the European Union.

The technology will allow cardiologists to recover digital ECGs from any compatible monitoring device and, after uploading them to the Cardiologics cloud, use the company’s technology to identify relevant cardiac events.

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