Trendlines : Limaca Medical Receives FDA 510(k) Clearance

Limaca Medical announced today 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 significantly superior quality and quantity of diagnostically relevant biopsy tissue. Limaca's First-In-Human EUS-Biopsy cases in suspect pancreatic cancer patients was published by iGIE, on 26 April 2023.