Biotechnology company United Therapeutics Corporation (Nasdaq: UTHR) announced on Monday that it has received U.S. Food and Drug Administration premarket approval for the LungFX device, the first system approved for centralised ex vivo lung perfusion of donor lungs that would otherwise not be used for transplantation.

The approval covers the use of LungFX to assess deceased-donor lungs outside the body before transplantation at centralised facilities. The application, submitted by United Therapeutics' wholly owned subsidiary Lung Bioengineering Inc, included safety and effectiveness data supporting the technology.

LungFX enables donor lungs initially preserved using cold static storage to be evaluated under normothermic perfusion and ventilation before potential transplantation into adult first-time lung transplant recipients. Lung Bioengineering plans to add the device to its centralised ex vivo lung perfusion services in 2027.

The company said it has performed approximately 1,100 ex vivo lung perfusion procedures to date using other approved devices, resulting in 600 donor lungs being accepted for transplantation.