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CorVista wins FDA clearance for AI heart failure assessment add-on
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Fusion42 · 29 July 2026 · Fusion42 review
The US Food and Drug Administration (FDA) has granted clearance for an AI-powered, non-invasive test by CorVista Health. The new add-on helps identify elevated pulmonary capillary wedge pressure (PCWP), a key indicator of heart failure, replacing the need for invasive catheter procedures in certain patient groups.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
The FDA is now clearing AI that replaces invasive cardiac catheters, not just AI that augments imaging. If your tool removes a painful clinical procedure from the equation, there is a proven regulatory pathway for it in the US.
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1 source · 29 Jul 2026
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