A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need.
Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and intermediate-risk patients with symptomatic, severe aortic stenosis.
A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.
Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.
Over the past decade, global regulations for medical technology have skyrocketed from around 500 to over 8000. Navigating the complexities of regulatory compliance is a daunting task—especially when faced with orthogonal aspects of regulations.
Medical Devices must be fully reimbursable – no out of pocket expenses – in Japan. So, how is reimbursement achieved for your medical device?
FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.
The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.
MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.