FDA grants breakthrough device designation for endoscopic ultrasound device
Limaca Medical announced it has received breakthrough device designation from the FDA for its Precision-GI endoscopic ultrasound biopsy device, according to a company press release.
Designed to obtain tumor tissue within or bordering the gastrointestinal tract, Precision-GI features an automated, rotational cutting needle that aims to decrease sample tissue fragmentation, inadequate sample tissue amount and blood contamination. Results from ongoing, comparative feasibility clinical studies have demonstrated the device’s ability to secure contiguous intact core tissue samples for pancreatic lesion diagnosis, as well as clean tissue samples that provide a high percentage of tumor content.
“Precision-GI is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy results for the evaluation of gastrointestinal malignancies,” Seth A. Gross, MD, clinical chief in the division of gastroenterology and hepatology at NYU Langone Health, said in the release. “Endoscopic biopsy is a highly specialized, high skill procedure. We welcome the innovation of Precision-GI which can provide automation and standardization of outcomes with less variation from operator to operator.
“Our field is driving toward patient-centric individualized cancer therapy, known as precision medicine, which requires consistently high quality and quantity of endoscopic biopsy tissue, enabling optimal matching of the tumor's genetic profile to personalize a patient's treatment plan.”
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