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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

Today: FDA approves United Therapeutics LungFX

Overview

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

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Timeline

April 2011 June 2026

3 events Latest: Today
  1. FDA approves United Therapeutics LungFX

    Today 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.

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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