The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
FDA will decrease its workforce by approximately 3,500 full-time employees, with a focus on streamlining operations and centralizing administrative functions. This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.
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.
Could MedTech find itself as the collateral damage if an RFK Jr. run HHS “goes wild” with FDA regulation of pharma and processed foods?
In the face of sweeping Medicare changes for 2025, millions of seniors face the challenge of navigating a complex landscape of new options, increased costs, and altered benefits. Innovative technologies are emerging as crucial tools for both patients and healthcare providers, offering detailed cost comparisons, network analyses, and benefit breakdowns.
Health equity can provide equal opportunity for patients to achieve the best care possible. Medtech leaders from Boston Scientific, Sequel Med Tech, and ZEISS Medical Technology share how healthcare delivery, data transparency, and industry collaboration can provide more value to patients.
Q2/24 Life Science and Health Care Law Updates by Hogan Lovells including key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) regulatory, corporate, compliance, competition, and privacy.
Information polarization affects public opinion. It can also affect investors. As we approach upcoming elections in different countries, it is crucial to understand how these political events could significantly reshape the landscape for MedTech investments. This article outlines an approach to help investors navigate and understand the interplay of political climates, cultural norms, and healthcare policies without getting emotionally attached to them. It emphasizes the importance of open dialogue, diversity, critical thinking, and cross-cultural collaborations to determine the true potential of MedTech innovations.
