Clinical trial of the high intensity focused ultrasound (HIFU) system for prostate cancer treatment commences at Georgetown University Medical Center under an investigational device exemption approved Jan. 8. Baylor University and the University of California at San Francisco also will participate in the 120-patient trial, which will enroll those who already have been treated with radiation but have experienced a recurrence
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
