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Precision GI Endoscopic Biopsy Device Receives 510(k) Clearance From FDA
Limaca Medical’s device had previously received a breakthrough device designation from FDA.
Limaca Medical's Precision GI Endoscopic Biopsy Device
Limaca Medical announced that its Precision GI Enoscopic Ultrasound Biopsy Device had received 510(k) clearance from FDA.
The device enables doctors to obtain biopsies for pancreatic and other life threatening GI cancers. According to Limaca, the automated device provides for more efficient and effective diagnosis.
Limaca CEO Assaf Klein said in a 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. 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."
