[Editor's note: Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker andat MedDeviceTracker].
The US FDA approved two original PMAs between March 26 and April 1.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Channel Medysystems’ Cerene cryotherapy for endometrial ablation and Fidia Pharma’s Triluron hyaluronic acid for knee pain.
[Editor's note: Complete historical data on global device approvals can be found in Medtech Insight's Approvals Tracker andat MedDeviceTracker].
The US FDA approved two original PMAs between March 26 and April 1.
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.