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# FDA Clears Focal Healthcare’s Prostate Biopsy Device
- URL: https://www.fdaweb.com/fda-clears-focal-healthcares-prostate-biopsy-device/
- Published: 2016-02-03T12:00:00.000Z
- Updated: 2026-09-15T02:32:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134675

> FDA has cleared a Focal Healthcare 510(k) for its targeted prostate biopsy device, Fusion Bx. The device is intended to assist clinicians in taking targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound “fusion” technology, according to the company. “MRI has the ability to see tumors in the prostate that ultrasound alone cannot,” it says. “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.” The device also provides 2D and 3D image visualization, and incudes review, manipulation, and analysis tools.