Medworld器械世界为您提供准确、及时、有效的医疗器械行业及医疗圈的市场动态，产品信息，技术进展等资讯！来源：Regulatory and Compliance of MDDIMedical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approval is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies don’t make it through.In this case study, I discuss the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S. I'll shares lessons learned as EDAP TMS began its 14-year journey, starting with the FDA pre-market approval (PMA) p
………………………………
