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Freenome Receives FDA Breakthrough Device Designation For Its Investigational Lung Cancer Screening Test SimpleScreen Lung

Aug 12, 2026 · 09:02 AM ET· updated 1h ago

The designation applies to the proposed use of SimpleScreen Lung in adults ages 50 to 80 who have at least a 20 pack-year smoking history and are not currently participating in guideline-recommended lung cancer

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Why It Matters

Freenome's lung cancer test got special approval help from the government, which means doctors think it could be really useful. This is a good sign that the company's idea might work, but we still have to wait and see if it actually helps people.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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