The FDA has granted breakthrough device designation to Precision-GI™ Endoscopic Ultrasound Biopsy Product, a tool that assists with performing a tumor biopsy, according to a press release by Limaca Medical.
“Precision-GI is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy results for the evaluation of gastrointestinal malignancies. Endoscopic biopsy is a highly specialized, high-skill procedure. We welcome the innovation of Precision-GI™ which can provide automation and standardization of outcomes with less variation from operator to operator,” stated Seth A. Gross, MD, clinical chief, Division of Gastroenterology and Hepatology, NYU Langone Health.