Precision-GI™ FDA Designated Breakthrough product and FDA cleared semi-automated motorized endoscopic biopsy device entering U.S. market
, /PRNewswire/ — The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Limaca Medical Ltd. (“Limaca”)’s Precision-GI™ motorized endoscopic biopsy device. Limaca’s endoscopic device is designed to obtain improved biopsy results for patients with suspected gastrointestinal cancers such as pancreatic, liver, and other GI-related and adjacent organs cancers and illnesses. The Precision-GI™ TPT grant is for up to three years beginning January 1, 2025, thus supporting patient access to Limaca’s new and innovative technology; previously, Precision-GI™ was granted the FDA’s Breakthrough Device Designation in 2022 and received clearance by the U.S. Food and Drug Administration (FDA) in August 2023.
“Receiving TPT approval for our Precision-GI™ product is a major accomplishment for Limaca, enabling greater patient access to the breakthrough device, standardizing higher quality outcomes for these critical endoscopic biopsy procedures, and …