CIMTEC congratulates Focal Healthcare for receiving FDA clearance for its Fusion Bx™ device for prostate biopsy
CIMTEC spin-off company, Focal Healthcare, announced on January 29, 2016 that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its targeted prostate biopsy device, Fusion Bx™. With the availability of Fusion Bx™, clinicians are no longer limited to the traditional systematic biopsy approach for diagnosis, but can instead accurately take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology.