In another safety communication from US FDA on LivaNova's Stockert 3T Heater-Cooler Systems, the agency adds recommendations for providers and patients to mitigate the risk of infection from the devices used during open-chest surgery.
In the ongoing saga of what to do about risks of infections from heater-cooler devices, US FDA has issued additional recommendations to providers and patients. In a June 12 safety communication, the agency listed additional steps users can take in conjunction with communications from LivaNova PLC, the maker of the most widely used heater-cooler devices.
LivaNova's Stockert 3T Heater-Cooler Systems have been under scrutiny in recent years after they were found to be associated with...
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
