Edwards Lifesciences is ramping up US commercialization of its Pascal Precision mitral valve transcatheter edge-to-edge repair device, the first US competitor for Abbott’s MitraClip. The FDA approved Pascal Precision earlier than the company expected, based on results of the CLASP IID trial.
Edwards Lifesciences is preparing to launch its Pascal Precision mitral valve transcatheter edge-to-edge repair (M-TEER) system in the US where it will be the first direct competitor for Abbott’s MitraClip.
Pascal Precision earned a CE mark in August and the US Food and Drug Administration approved it on 14...
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
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.
