US clearance for portable breast biopsy device:
This article was originally published in Clinica
The FDA has granted 510(k) marketing clearance to Ethicon Endo-Surgery's Mammotome Hand Held, a portable version of the Mammotome breast biopsy device, for use in physician surgeries and clinics. The device's probe is inserted into the suspect area of the breast under ultrasound guidance and the tissue for examination is cut and aspirated by a rotating needle. The procedure takes under an hour and leaves only a 6mm incision, says Johnson & Johnson subsidiary Ethicon.