Focal Healthcare

Focal Healthcare has developed the Fusion Bx™ platform—a CE-marked, FDA-cleared, and Health Canada-approved MRI/Ultrasound fusion-guided prostate biopsy device. The technology improves accuracy in diagnosing clinically significant prostate cancers by enabling urologists to target suspicious lesions identified on multiparametric MRI. The solution supports both transrectal and transperineal approaches and integrates with focal therapies like IRE and HIFU. Clinical adoption aligns with updated European guidelines recommending mpMRI prior to biopsy followed by targeted sampling when indicated. The company’s products are designed for ease of use, high accuracy, workflow efficiency, and broad accessibility across clinics of all sizes.