Devices

Praxis 510(k) for Biopsy Device Cleared

FDA has cleared a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device. “Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is used for the diagnosis and staging of lung cancer,” the company says. “This procedure is performed by inserting a long, flexible fine needle through a bronchoscope for biopsy and pathological analysis. The cellular material collected can be viewed under a microscope to determine if a mass is malignant and identify tumor-specific mutations to guide treatment.”

The device is designed to “enhance” the outcomes of this procedure, according to Praxis, adding that it is powered by a motor that rotates the needle during biopsy to help “cellular harvesting.” “This unique rotary motion enables the needle to shear off large tissue samples that can help physicians make a comprehensive diagnosis,” it adds.

Praxis 510(k) for Biopsy Device Cleared

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