Urology FDA approvals of 2016
Targeted prostate biopsy device receives FDA clearance
Focal Healthcare Inc. received 510(k) FDA clearance for its targeted prostate biopsy device, Fusion Bx. It is designed to take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound fusion technology. According to the company, fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy. By accurately determining the location and extent of the cancer, this procedure also allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer. The 510(k) clearance includes the use of Fusion Bx for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2-D and 3-D image visualization, including review, manipulation, and analysis tools.
For more information, visit http://focalhealthcare.com/.