Praxis Medical Announces FDA Clearance of the EndoCore EBUS-TBNA Biopsy Device
Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device.
- Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device.
- This procedure is performed by inserting a long, flexible fine needle through a bronchoscope for biopsy and pathological analysis.
- The device is powered by a motor that rotates the needle during biopsy to facilitate cellular harvesting.
- “We expect the EndoCore device will collect larger samples of tissue with higher cellularity which could translate to higher success rates for ancillary testing.