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.
AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.
Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.
The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would represent roughly 10% of the program’s total staffing.
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
According to CDER Director Patrizia Cavazzoni, CDER’s new Center for Real-World Evidence Innovation represents a major step forward in efforts to unlock the full potential of RWD to inform clinical and regulatory decisions.
EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help? AI-driven tools and automations enhance productivity,…
With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous submissions to multiple national regulatory authorities, paving the way for a much anticipated fully digital, single global dossier.
