This month, Hisky Medical’s flagship CelTouch Confocal Laser Endomicroscopy (CLE) system has officially obtained EU-MDR certification. Following its previous FDA 510(k) clearance in the United States, this EU authoritative certification verifies that the product fully complies with the highest international standards in quality, safety and clinical performance, marking a key milestone in the company’s global expansion journey.

Equipped with industry-leading core technologies, the CelTouch CLE system delivers high-precision and high-efficiency clinical diagnostic capabilities. It enables real-time in vivo cellular imaging with 1μm ultra-high resolution and a frame rate of 120 fps, along with up to 1000× magnification to achieve visualization equivalent to optical biopsy. Featuring an ultra-slim 0.8 mm probe, the system adapts to complex and challenging gastrointestinal examination scenarios. Integrated AI-assisted image analysis effectively improves the accuracy and reliability of clinical diagnosis. In addition, the reusable probe design balances outstanding clinical performance and cost efficiency, greatly enhancing clinical accessibility and application value.