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Limaca Medical has developed and commercialized Precision-GI, an FDA 510(k)-cleared and FDA Breakthrough-designated endoscopic ultrasound-guided motorized biopsy device that has demonstrated higher tissue yield, better histology scores, and shorter procedure times versus manual fine needle biopsy in early clinical studies, and has now entered the US market supported by CMS Transitional Pass-Through Payment and additional clinical data.[2][4][5]
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