FDA grants breakthrough device designation for endoscopic ultrasound device

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 forRead More

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