Focal Healthcare Gets FDA’s OK for Prostate Fusion Biopsy Device

The FDA has given its nod to Focal Healthcare’s Fusion Bx 2.0, the second generation of the prostate fusion biopsy device.

The device, which uses an MRI to mark potential lesions and ties it to live ultrasound images, makes a 3D model of the patient’s prostate.

The prostate model is used by urologists to target specific regions for biopsy, enabling more accurate and effective prostate cancer diagnoses.