FDA clears iScan digital pathology hardware

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BioImagene has received FDA 510(K) clearance for its Pathiam system with iScan for assessment of HER2/neuimmunohistochemistry tests. Pathiam provides users with a menu of validated protocols, digital archiving and retrieval, flexible reporting and integration with LIS systems.

The scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients to determine if they are candidates for treatment with the breast cancer drug Herceptin.

The iScan, part of BioImagene's total digital pathology system, is an automated digital slide scanner that provides high-speed scanning of slides at 20X and 40X with superior image quality. iScan includes features like a high-capacity autoloader for walk-away scanning of up to 160 slides and an automated slide detection system, according to Ajit Singh, PhD, CEO of BioImagene.