Shots:
- The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3’25
- Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung nodules while RELIVE showed that radiologists aided by eyonis LCS outperformed those who were unaided
- eyonis Lung Cancer Screening is an AI-powered computer-aided detection & diagnosis (CADe/CADx) Software as a Medical Device (SaMD) that utilizes ML to analyze imaging data from low-dose computed tomography (LDCT)
Ref: Median Technologies | Image: Median Technologies | Press Release
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