FDA Grants Breakthrough Device Designation to Freenome's Blood-Based SimpleScreen™ Lung Cancer Screening Test
Freenome announced that the U.S. FDA granted Breakthrough Device Designation to SimpleScreen™ Lung, its investigational blood-based lung cancer screening test. The designation applies to the company's early cancer detection product.
Why it matters — Breakthrough Device Designation could facilitate a faster development and review path for Freenome's lung cancer screening test, potentially advancing its pipeline toward the market.