Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA introduces new generative AI tool
- The U.S. Food and Drug Administration has introduced a new generative artificial intelligence tool called Elsa ahead of schedule. According to Fierce Biotech, Elsa is designed to assist with clinical protocol reviews, scientific evaluations and identifying high-priority inspection targets.
- Elsa’s rollout is part of the FDA’s broader strategy to integrate AI across the agency, aiming to enhance efficiency and reduce review times for new therapies.
Medtech industry facing financial challenges due to tariffs
- According to Fierce Biotech, major medtech companies are facing potential financial challenges due to tariffs on Chinese imports, which could disrupt supply chains and increase costs.
- The medtech sector is advocating for tariff exemptions, warning that the duties could negatively affect patient access to essential medical technologies and hinder investments in research and development.
FDA ends efforts to regulate lab-developed tests after court ruling
- The FDA chose not to appeal a U.S. District Court ruling that blocked its final rule aimed at regulating lab-developed tests, ending its efforts to expand regulatory authority over these tests.
- According to MedTech Dive, the decision is seen as a victory for lab professionals and patient care, as the proposed changes were feared to jeopardize test innovation and potentially force smaller labs to close.
Proposal for cuts and restructuring for HHS
- The recent detailed 2026 budget proposal includes cuts to the Department of Health and Human Services (HHS), particularly targeting the National Institutes of Health (NIH) with nearly a 50% reduction in its budget, which, according to MedTech Dive, could affect biomedical research and public health infrastructure.
- The proposal aims to consolidate HHS divisions, eliminate numerous programs, and create new agencies, but faces some criticism for potentially undermining scientific progress and public health efforts.
FDA clears first AI tool for predicting breast cancer risk from mammograms
- A platform created by Clairity, Inc., a digital health innovator, received FDA clearance to predict five-year breast cancer risk from routine screening mammograms, using AI to analyze subtle imaging features.
- According to Fierce Biotech, the AI-powered tool aims to enhance personalized follow-up care, potentially reducing late-stage diagnoses and improving early detection and prevention strategies for breast cancer.
For more insights in life sciences, check out RSM’s industry outlook.
