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.
Industry groups hoping to lessen impacts of Donald Trump’s “Liberation Day” plans on medical products and MedTech development sent letter to the U.S. Trade Representative.
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.
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.
With a new executive order to leave the World Health Organization, the Make America Healthy Again (MAHA) movement is driving new policy and promises for faster time to market for product innovation. MedTech start-ups are keen to capitalize on the opportunity, yet funding to push product through early product phases – concept and design through clinical studies and post-market surveillance – can be complex. Daniele Viappiani of GC1 Ventures offers strategies for MedTech start-ups to find the right investors.
Leveraging awareness communications to grasp the potential opportunity for medical devices designed to monitor health and chronic illnesses offered by the new US administration.
The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F. Kennedy Jr as Department of Health and Human Services secretary are likely to bring a series of crucial changes that will affect the medical device market globally. Manufacturers everywhere are addressing their attention to the US market and waiting for new decisions to be made. In particular, deregulation is on the cards for the sector and the biggest concern is the restructure of the Food and Drug Administration (FDA), as a reduction in regulatory red-tape, though favoring increased competition, could also dangerously shrink examination processes.
careviso Survey Highlights Major Communication Gaps in Healthcare, Impacting Financial Transparency and Patient Experience
“Tariffs may have negative consequences for a continually growing market due to an aging population and the increasing prevalence of long-term illnesses. Companies will be forced to increase prices to make up for losses incurred by the proposed tariffs which may cause supply chain disruptions.”
