focal healthcare
Focal Healthcare is developing MR Fusion prostate biopsy and therapy devices
Focal Healthcare's vision is to improve the lives of prostate cancer patients by developing imaging technology that is accurate, efficient, and accessible to enable better diagnosis and treatment.
Focal’s biopsy system enables urologists to co-register MRI prostate images with live ultrasound to accurately target suspicious cancer regions during transrectal ultrasound (TRUS) biopsy procedures.
On January 29, 2016, Focal Healthcare announced that it 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.