www.fdanews.com/articles/198831-transmed7-soft-tissue-biopsy-devices-cleared
TransMed7 Soft-Tissue Biopsy Devices Cleared
September 2, 2020
TransMed7 has earned 510(k) clearance from the FDA for its Concorde US and Concorde ST soft-tissue biopsy devices.
Concorde US is designed for ultrasound guidance for handheld use, but will also be available with an optional stage-mount adapter. The Concorde ST is designed for radiosurgery and imaging-guidance biopsy procedures.
Both devices can gather multiple samples and may be configured for forward- or combined forward- and side-coring biopsy procedures.