Focal Healthcare receives 510(k) clearance from the FDA for their targeted prostate biopsy device, Fusion Bx

Toronto, ON – January 29, 2016 – Focal Healthcare Inc.TM, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their targeted prostate biopsy device, Fusion Bx TM. 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.

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