Limaca Medical announced that its Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This follows Limaca’s receipt of FDA Breakthrough Device Designation for its Precision GI.
Precision GI obtains biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than current products. The automated device is designed to provide for more efficient and effective diagnosis of GI cancers by yielding superior quality and quantity of diagnostically relevant biopsy tissue.
“While all existing endoscopic ultrasound fine needle biopsy (EUS-FNB) devices require manual hand operation, Precision GI features a unique motorized, automated rotational cutting needle for successful, safe, and high-quality tissue acquisition,” said Iyad Khamaysi, MD, director of the Invasive Endoscopy Unit at the Rambam Health Care Campus. “Today’s endoscopic biopsy devices have limitations in consistently obtaining quality tissue with sufficient quantity, which can result in sample tissue fragmentation, inadequate tissue amount, and blood contamination.”
Limaca’s First-In-Human EUS-Biopsy cases in suspect pancreatic cancer patients was published by iGIE, on 26 April 2023.
“Our first series of patients have demonstrated that Precision GI enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions,” said Assaf Klein, Limaca CEO. “The clean, non-contaminated tissue samples provide a high percentage of tumor content, with less blood and extraneous fluids. FDA clearance allows us to bring Precision GI to market to fulfill our mission to always achieve precise, efficient, and definitive biopsy samples.”
