The challenging landscape of medical device approval in localized prostate cancer.

Findings of research using modern multiparametric MRI have provided clinicians with reliable targets for guiding prostate biopsy sampling and directing targeted therapy, often termed focal therapy, to specific areas of the prostate. This emerging shift in treatment strategy from a whole-gland approach to a lesion-specific or region-specific approach requires novel medical devices. The rules regulating the approval and clinical use of such new devices often differ between the USA and Europe, and these differences can affect the treatments that patients receive. Current regulatory pathways for approval of various image-guided biopsy and focal therapy devices intended to be used in patients with prostate cancer are discussed in detail. Finally, we offer some perspective on the current status of research in the field, and propose a potential roadmap towards the establishment of timely, safe and standardized criteria for optimal evaluation of novel image-guided devices for treatment of patients with localized prostate cancer.