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Limaca Medical Receives FDA 510(k) Clearance

Limaca Medical Receives FDA 510(k) Clearance for its Breakthrough Precision GI™ Endoscopic Biopsy Device

11 September 2023


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.

This news was published on PRNewswire,BioWorld and Medical Device Network.

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. 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.
Prof. Iyad Khamaysi, MD, Director of the Invasive Endoscopy Unit at the Rambam Health Care Campus.

Our first series of patients have demonstrated that Precision GI™ enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions. 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.
Assaf Klein, Limaca CEO

We are pleased with FDA’s clearance of Precision GI™, following our FDA Breakthrough Device Designation. We are dedicated to our mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal of achieving faster, more efficient biopsy yield with highly consistent results. We look forward to soon bringing Precision GI™ to patients in the US.
Carl Rickenbaugh, Limaca Vice Chair

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