Focal Healthcare Aims to Make Targeted Prostate Biopsy Procedures Accessible

Focal Healthcare Inc.^TM 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.
According to the company’s press release:

MRI has the ability to see tumors in the prostate that ultrasound alone cannot. Thus, by fusing previously-acquired MR images to live ultrasound, clinicians can target suspicious tumors when taking biopsy samples. Fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy [1]. In addition, by accurately determining the location and extent of the cancer, this procedure allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer.

Chicuong La, CEO of Focal Healthcare comme

Focal Healthcare was founded to bring state of the art procedures into clinics of all sizes. Fusion Bx was developed with both the patient and doctor in mind and we are excited that this clearance will help us provide patients with broad access to this valuable procedure.

Click here to view the full press release.