Galen™ Second Read™

Galen™ Second Read™ is a cloud-hosted software device that analyzes digitized whole slide images from prostate core needle biopsies to identify cases initially diagnosed as benign that may contain prostate cancer. When the device detects tissue suspicious for adenocarcinoma, it flags the slide and displays a heatmap highlighting areas of concern for pathologist review, with the understanding that final diagnosis remains the pathologist's responsibility.

Both Galen Second Read and predicate Paige Prostate are internet browser-based software using deep convolutional neural networks to analyze H&E-stained FFPE prostate biopsy images from Philips UFS scanners. Key differences: Galen provides case- and slide-level alerts with heatmaps for initially benign cases, while Paige provides a single coordinate (X,Y) location after pathologist diagnosis; Galen uses its own interface versus Paige's FullFocus viewer; Galen includes panning, zooming, and distance measurements versus Paige's additional color manipulation and annotation functions.

Not stated in this summary.

Galen Second Read shares the same intended use (identifying prostate cancer in biopsies using AI-assisted analysis of digital pathology images), specimen type (H&E FFPE prostate core needle biopsies), scanner platform (Philips UFS), and software architecture (neural network-based internet application) as the predicate Paige Prostate. Although the devices differ in workflow (pre- versus post-diagnosis analysis) and output presentation (heatmap versus coordinates), these differences do not raise new safety or effectiveness questions because both function as adjunctive tools requiring pathologist review and confirmation, and clinical validation demonstrates Galen achieves comparable or superior sensitivity (81-93.9%) and specificity (87.9-91.6%) for cancer detection.