FDA
Breakthrough Device Designation
  • GRANTED
  • March 2026
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Next-gen cardiac intelligence.

Combining personalized calibration, wearables, and AI for proactive heart failure care.

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May 27, 2026 No Comments

FDA Breakthrough Device Designation GRANTED March 2026 Learn more Contact The Coredio Blog Read our latest blogs to understand more

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Join the clinicians who are exploring the future of cardiovascular monitoring

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FDA

Disclaimer: Coredio CPSE™ has received FDA Breakthrough Device Designation. The device is not yet cleared by the FDA for commercial use. Indications for Use are subject to FDA review under the 510(k) process. 

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