The US FDA has cleared a new endoscopy system from Olympus along with two compatible gastrointestinal endoscopes for the diagnosis and treatment of a range of GI issues.
The Food and Drug Administration’s clearance of a new endoscopy system provides physicians with advanced technology to treat their patients, manufacturer Olympus said.
The Olympus EVIS X1 endoscopy system is used to diagnose, treat, and observe diseases and disorders of the upper and...
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.
