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FDA Clears Praxis Medical's Novel EndoCore EBUS-TBNA Biopsy Device for Clinical Use

Praxis Medical has made an important announcement regarding the EndoCore EBUS-TBNA fine needle biopsy device. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for this cutting-edge device, which aims to enhance the diagnostic and staging capabilities of endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA), commonly used in the context of lung cancer.

EBUS-TBNA involves the insertion of a flexible fine needle through a bronchoscope to collect tissue samples for pathological analysis. These tissue samples are vital in determining the malignancy of masses and identifying specific tumor mutations, which are critical for guiding treatment decisions. The EndoCore represents a novel advancement in this field, featuring a motor-driven rotary motion that brings innovation to the biopsy process.

This unique rotary motion enables the needle to obtain more substantial tissue samples, significantly aiding physicians in making comprehensive diagnoses. The improved sensitivity, diagnostic yield, and ancillary testing capabilities offered by the EndoCore promise to streamline the diagnostic process for a variety of adenopathy cases, all while maintaining procedural efficiency and low complication rates. This advancement is especially noteworthy for rarer tumors, metastatic diseases, lymphoma, and benign conditions like sarcoidosis, where traditional EBUS-TBNA often falls short in providing satisfactory results.

The introduction of these innovative products underscores Praxis Medical's dedication to revolutionizing the way fine needle biopsies are conducted, aligning with their overarching mission to enhance the well-being of patients through technological progress.

Source: https://www.businesswire.com/news/home/20231017570494/en/Praxis-Medical-Announces-FDA-Clearance-of-the-EndoCore-EBUS-TBNA-Biopsy-Device

 

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