A rapidly aging population, along with economic growth and rising industrialization, is driving a big increase of the disease.
Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.
The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.
Here are the most read articles of the year.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
While the road to bringing a medical device to market is often bumpy, working with an experienced and knowledgeable partner can help navigate the process and potentially avoid some of the bumps.
This mode of personalized medicine helps doctors make more informed decisions related to drug therapies.
A gap assessment provides a toolbox for the decision-making process.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
It is time to extend AI’s use into labor & delivery departments, where the technology can help guide care teams to mitigate risks and make informed decisions.