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# Class 2 for Predictive Cardiovascular Indicator
- URL: https://www.fdaweb.com/class-2-for-predictive-cardiovascular-indicator/
- Published: 2022-02-11T12:00:00.000Z
- Updated: 2026-09-14T17:32:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151143

*Federal Register* notice: FDA has classified the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls). The action is in response to an Edwards Lifesciences de novo classification request for its Acumen Hypotension Prediction Index Feature Software. The agency has identified it as being a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-03096.pdf?ref=fdaweb.com).