Endoscopic Ultrasound Biopsy Modality Gets FDA Nod

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Precision GI^TM Endoscopic Ultrasound (EUS) Biopsy Device, which may facilitate improved quality and quantity of biopsy tissue.

For pancreatic cancer and other gastrointestinal (GI) cancers, the Precision GI ultrasound device enables clinicians to obtain “significantly superior quality and quantity of diagnostically relevant biopsy tissue,” according to Limaca Medical, the manufacturer of the Precision GI Endoscopic Ultrasound Biopsy Device.

Iyad Khamaysi, M.D., said the automation with the Precision GI ultrasound tool provides a notable contrast to other endoscopic biopsy modalities.

“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,” noted Iyad Khamaysi, M.D., the director of the Invasive Endoscopy Unit at the Rambam Health Care Campus in Haifa, Israel.