In their updated safety communication, the US FDA (Food and Drug Administration) states that the safety and efficacy of robotically assisted surgical (RAS) devices is still to be determined in the prevention and treatment of breast cancer. While the use of RAS devices are approved for procedures including hysterectomies, prostatectomies, and colectomies, the devices are still yet to be evaluated based on outcomes of overall survival, recurrence, and disease-free survival in cancer. In the safety communication that the FDA issued in 2019, it illustrated that the FDA expects that the effectiveness of RAS devices in mastectomies, “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.” It is unknown whether the FDA will require manufacturers to track these outcomes in the future as part of clinical trials performed under an investigational device exemption (IDE)

Read more here.