Shots:
- The US FDA has granted 510(k) clearance to eyonis Lung Cancer Screening (LCS), an AI/ML-powered CADe/CADx software, to detect & diagnose lung cancer
- eyonis LCS analyzes LDCT imaging to help radiologists detect & characterize pulmonary nodules, enabling earlier diagnosis; in testing it showed 93.3% sensitivity, 92.4% specificity & 99.9% NPV, minimizing false positives & unnecessary follow-ups
- The company will share commercial launch details in coming wks. & will advance European regulatory review, with CE marking expected in Q2’26
Ref: Businesswire | Image: Median Technologies | Press Release
Related News: Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
