The deal will help strengthen the Edwards portfolio of smart monitoring technologies.
The device approvals address critical patient need.
The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
“We don’t know how long the shutdown is going to continue,” says the association’s President and CEO Scott Whitaker.
The challenges will continue to keep medtech manufacturers and other stakeholders in the healthcare industry on their toes.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
The companies are finally putting to bed all outstanding patent disputes.
It’s time to address this healthcare problem.
Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.