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FDA approves United Therapeutics LungFX to reassess discarded donor lungs

FDA approves United Therapeutics LungFX to reassess discarded donor lungs

New Capabilities

First proprietary system cleared for centralized ex vivo lung perfusion aims at the 80% of donor lungs left unused

June 29th, 2026: FDA approves United Therapeutics LungFX

Overview

Updated Jun 29

More than 8 in 10 donor lungs recovered from deceased donors never reach a patient. On June 29, 2026, the FDA approved a device built to change that math. United Therapeutics won premarket approval for LungFX, a system that keeps donor lungs warm, ventilated, and pumped with fluid outside the body so transplant teams can re-examine organs they had already rejected.

Lungs are the hardest solid organ to transplant. Roughly 20% of lungs from deceased donors get used, against about 90% of kidneys. LungFX is the first company-owned system cleared for centralized perfusion, meaning the assessment happens at a dedicated facility instead of at each hospital. If even a fraction of discarded lungs pass a second look, the transplant pool grows without adding a single new donor.

Why it matters

Thousands of people die each year waiting for lungs; a tool that rescues even some of the 80% now discarded could shorten that wait.

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Key Indicators

80%+
Donor lungs unused
Share of recovered donor lungs that currently go untransplanted.
~1,100
EVLP procedures run
Perfusion procedures Lung Bioengineering has performed using earlier approved systems.
~600
Lungs accepted for transplant
Organs from those procedures judged good enough to transplant.
20 hours
Max preservation window
Total time a lung can stay preserved under the approved labeling.

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People Involved

Organizations Involved

Timeline

April 2011 June 2026

3 events Latest: June 29th, 2026 · 2 months ago
  1. FDA approves United Therapeutics LungFX

    Latest Regulatory

    The FDA grants premarket approval to LungFX, the first proprietary system cleared for centralized lung perfusion. A commercial rollout is planned for 2027.

  2. FDA approves first centralized perfusion system

    Regulatory

    United Therapeutics wins approval for the Xvivo XPS device and Steen Solution, used to run centralized ex vivo lung perfusion.

  3. Toronto team publishes clinical proof of lung perfusion

    Research

    A Toronto group reports in the New England Journal of Medicine that perfused marginal lungs transplant about as well as standard ones.

Scenarios

1

United Therapeutics launches commercial LungFX service in 2027

Likely Resolves by End of 2027

Discussed by: United Therapeutics investor guidance; Benzinga

The company has said it expects to put LungFX into clinical use in 2027. A launch would mean transplant centers start sending discarded lungs to Lung Bioengineering for assessment on the new system. The main risks are manufacturing scale-up and the time needed to train and contract with transplant programs.

2

National lung transplant counts rise as perfusion scales

Possible Resolves by End of 2028

Discussed by: Transplant researchers; published EVLP outcome studies

One program that adopted earlier perfusion technology reported roughly 12% more lung transplants a year. If centralized perfusion spreads through LungFX, U.S. lung transplant totals could climb. The signal is national registry data showing more lung transplants in a year than the one before. Attribution to LungFX specifically will be hard to isolate from other trends.

3

Adoption stalls and LungFX volumes stay flat

Unlikely Resolves by End of 2028

Discussed by: Skeptics citing the modest survival data behind earlier perfusion approvals

Clinical trials of earlier perfusion systems showed survival roughly on par with standard lungs, not clearly better. Hospitals may be slow to route organs through a centralized service if reimbursement and logistics stay difficult. In this case, perfusion remains a niche tool and the discard rate barely moves.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

April 2011

Toronto clinical lung perfusion trial (2011)

Surgeon Shaf Keshavjee and colleagues at Toronto General Hospital perfused high-risk donor lungs and transplanted those that passed. They reported the results in the New England Journal of Medicine.

Then

Perfused marginal lungs showed outcomes close to standard donor lungs.

Now

The study turned ex vivo lung perfusion from a lab idea into accepted clinical practice.

Why this matters now

It is the clinical evidence base that approvals like LungFX rest on.

April 2019

FDA approval of the Xvivo perfusion system (2019)

The FDA approved the Xvivo XPS device and Steen Solution for centralized lung perfusion, lifting an earlier cap that had limited use to 8,000 patients a year. The trial reviewed 332 donor lung sets.

Then

Centralized perfusion could now be offered without the patient-number limit.

Now

It set the regulatory template that LungFX followed seven years later.

Why this matters now

LungFX is United Therapeutics' own system replacing the third-party device it first built its service on.

2021

TransMedics Organ Care System approvals (2021)

The FDA approved TransMedics warm-perfusion systems that keep donor hearts and lungs functioning during transport, including organs from donation after circulatory death.

Then

Surgeons gained a way to use organs that cold storage would have ruled out.

Now

Machine perfusion became a mainstream method for widening the donor pool across organ types.

Why this matters now

It shows the pattern LungFX joins: perfusion technology turning rejected organs into usable ones.

Sources

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