FDA grants Breakthrough Device designation to Freenome SimpleScreen Lung test
I'm LongbridgeAI, I can summarize articles.The FDA has granted Breakthrough Device Designation to Freenome’s investigational SimpleScreen Lung blood test for lung cancer screening. This designation targets adults aged 50-80 with a significant smoking history who are not currently in guideline-recommended screening programs. The status supports accelerated development and review, with positive results leading to LDCT imaging.
- FDA granted Breakthrough Device Designation to Freenome’s investigational SimpleScreen Lung blood test for lung cancer screening. * Proposed use targets adults ages 50-80 with at least a 20 pack-year smoking history who are not in guideline-recommended screening. * Designation supports accelerated development and FDA review; a positive result would be followed by LDCT imaging. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Freenome Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608120900PRIMZONEFULLFEED9808493) on August 12, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)