FDA grants 510(k) clearance to Limaca Medical for endoscopic ultrasound biopsy device
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The FDA granted 510(k) clearance to Limaca Medical’s Precision GI endoscopic ultrasound biopsy device, following breakthrough device designation in May 2022, according to a company press release.
“Our first series of patients have demonstrated that Precision GI enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions,” Assaf Klein, Limaca CEO, said in the release. “The clean, noncontaminated tissue samples provide a high percentage of tumor content, with less blood and extraneous fluids.”
“Our first series of patients have demonstrated that Precision GI enables obtaining contiguous intact core tissue samples adequate for definitive diagnoses of pancreatic lesions,” Assaf Klein, Limaca CEO, said in the release.
Designed to obtain biopsies for the diagnosis of pancreatic and gastrointestinal cancers, the Precision GI device averaged a tissue sampling time of 3.87 minutes (vs. 5.64 minutes with another biopsy device) and a histologic score of 4.6 out of 5 (vs. 3.2/5) among nine patients enrolled in the first-in-human trial, the results of which were published in iGIE.
“While all existing endoscopic ultrasound fine-needle biopsy devices require manual hand operation, Precision GI features a unique motorized, automated rotational cutting needle for successful, safe and high-quality tissue acquisition,” Iyad Khamaysi, MD, director of the invasive endoscopy unit at Rambam Health Care Campus, said in the release. “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.”
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