A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.
As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
PharmStars CEO Naomi Fried spoke with Medtech Insight about the Boston-based virtual accelerator, which brings together digital health-focused start-ups with pharmaceutical companies to accelerate deals. Executives from Elemeno Health, Head Diagnostics and JOGO Health who participated in the PharmaU program and final pitching event to PharmStars’ pharma members talked about their experiences, the value proposition and challenges in securing a pharma deal.
Patient safety group ECRI put AI-enabled applications at the top of its annual list of health hazards for 2025. The group says that despite its enormous potential, artificial intelligence presents the most significant risk among health technologies going into the new year.
Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight
A Medtronic-funded study will use Tempus’ Next Cardiology platform to identify aortic and mitral heart valve disease patients who are being undertreated.
The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.
The head of the Korea Regulatory Science Center discusses why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.
In its inaugural two-day meeting, the FDA Digital Health Advisory Committee discussed the promise of generative AI-enabled medical devices as well as challenges the agency faces in premarket evaluation, benefit/risk analysis, and postmarket monitoring.
Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.
