FDA approves LungFX for centralized ex vivo lung perfusion

The U.S. Food and Drug Administration has granted premarket approval to United Therapeutics Corporation’s LungFX device for use in centralized ex vivo lung perfusion, or EVLP, according to the company. The device is designed to let clinicians assess donor lungs outside the body after procurement and before transplantation. The approval was announced on June 29, 2026.

The submission to the FDA was made by Lung Bioengineering Inc., a wholly owned subsidiary of United Therapeutics, which is a public benefit corporation traded on Nasdaq under the ticker UTHR. The company said the application included safety and effectiveness data supporting use of LungFX for EVLP in a centralized facility setting.

LungFX is indicated for centralized, ex vivo evaluation of deceased-donor lungs, including both single and double lungs, that an organ procurement organization could not place for transplantation using direct-to-recipient procurement and preservation procedures with any matched candidate. In other words, the device is intended for lungs that were initially not placed through standard matching pathways and that can be re-assessed before a final transplant decision.

According to the announcement, the device provides normothermic perfusion and ventilation of donor lungs that were first stored using cold static preservation solution. The goal is to allow re-evaluation in a controlled environment of whether the lungs are suitable for transplantation.

The approved use applies to male and female patients age 18 and older with end-stage lung disease who are awaiting a first-time single or double lung transplant. If lungs are accepted for transplantation after LungFX evaluation, they require a second period of cold static storage. The total preservation time for transplanted lungs is not intended to exceed 20 hours, according to the announcement.

United Therapeutics said Lung Bioengineering has already performed 1,100 EVLP procedures using other approved devices and that 600 lungs have been accepted for transplant as a result. The company said it expects to add LungFX to its available services in 2027.

In the company’s announcement, Martine Rothblatt, Ph.D., chairperson and chief executive officer of United Therapeutics, said the approval is a step toward reducing the number of donor lungs that are not transplanted. Rothblatt said more than 80% of donor lungs are left behind instead of being transplanted. She also said the FDA approval marks an important milestone in the company’s path toward using advanced technologies to create an unlimited supply of transplantable organs.

Kenneth McCurry, M.D., director of the Cleveland Clinic Enterprise Transplant Center and an investigator in the LungFX pivotal trial, said too many donor lungs go unused today. He said EVLP with this device provides additional clinical data to transplant teams to help determine whether donated lungs that might otherwise go unused are suitable for transplant. McCurry also said work with Lung Bioengineering over the last ten years has significantly increased the number of patients his team has been able to successfully transplant.

Brandi Zofkie, M.P.H., associate vice president of Lung Bioengineering, said LungFX is the first EVLP device approved specifically for use in a fit-for-purpose centralized facility. She said that approach expands access for transplant programs without requiring them to build EVLP capabilities in their own hospitals. Zofkie also said it strengthens United Therapeutics’ platform for advancing new technologies designed to enhance donor lung function.

Lung Bioengineering operates centralized EVLP facilities in Silver Spring, Maryland, and Jacksonville, Florida. At those locations, the company performs procedures designed to extend preservation time and assess donor lungs that might otherwise be deemed unsuitable for transplant. The new approval supports that model by allowing evaluation to be carried out in a dedicated facility rather than at each transplant center.

The article notes that the 510(k) clearance and PMA pathways for devices such as LungFX reflect a tiered, risk-based review system that is distinct from the multiphase trials required for drugs. For physicians, that difference matters because it affects how quickly new transplant-support technologies can move from clinical study to bedside use.

The approval also arrives as transplant medicine continues to look for ways to expand the usable donor organ pool. Discarded or underused organs have remained a persistent issue across the field, and interest has grown in approaches that can extend preservation windows or improve real-time assessment of organ viability before transplant.

Ex vivo perfusion systems have attracted attention because they allow transplant teams to observe organ function in real time instead of relying only on donor history and visual inspection at procurement. For doctors caring for patients with end-stage organ disease, the practical effect of these technologies is often measured by waitlist time. The article says that any approach increasing the share of procured organs that are ultimately transplanted can potentially shorten time to transplant and reduce waitlist mortality, especially for patients who are sensitized, have rare blood types, or otherwise face longer odds of finding a match.

Centralized service models can also reduce the capital and staffing burden on individual hospital programs. By moving evaluation to a dedicated facility, transplant centers that could not otherwise justify building or maintaining EVLP infrastructure in house may still gain access to organ-assessment technology.

The approval of LungFX gives United Therapeutics a device specifically authorized for centralized EVLP of donor lungs. According to the company, that authorization is intended to help transplant teams re-evaluate lungs that were not placed through standard procedures and may otherwise have been discarded. The company’s announcement emphasized the device’s role in controlled reassessment before transplantation decisions are made.

LungFX’s approval does not change the fact that the lungs involved must still meet transplant requirements after re-evaluation. The announcement states that accepted lungs need a second period of cold static storage and that total preservation time is not intended to exceed 20 hours. Those limits are part of the approved use described by the company.

The article does not report additional clinical outcomes from the pivotal trial beyond the company and investigator statements, and it does not provide further details about specific trial design, enrollment, or comparative results. It also does not say how many centers will use LungFX once it becomes available in 2027.

Still, the approval marks a notable development for lung transplantation because it combines centralized processing, donor-lung assessment, and preservation in one FDA-cleared pathway. For transplant programs, that may mean more options for evaluating lungs that might otherwise remain unused.

More broadly, the decision reflects ongoing interest in technologies that can make better use of organs that are procured but not transplanted. In lung transplantation, where supply remains limited, a device that helps teams reassess donor lungs in a controlled setting may be one more tool for increasing access to transplant for adults with end-stage lung disease.