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United Therapeutics Corporation Announces FDA Approval of the LungFX™ Device for Centralized Ex Vivo Lung Perfusion

$UTHRPress releaseJun 29, 2026, 6:30 AM ETRead the release

United Therapeutics received FDA premarket approval for the LungFX device, the first device cleared for centralized ex vivo lung perfusion to assess donor organs outside the body. The company intends to add LungFX to its subsidiary Lung Bioengineering's service offerings in 2027, aiming to increase the utilization of donor lungs that are currently discarded.

Key figures

Drug Name
LungFX
Evlp procedures to date
1100
Expected service launch year
2027
Lungs accepted for transplant
600

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