The integration of generative AI (GenAI) and large language models (LLMs) in healthcare presents both unprecedented opportunities and challenges, necessitating innovative regulatory approaches. GenAI and LLMs offer broad applications, from automating clinical workflows to personalizing diagnostics. However, the non-deterministic outputs, broad functionalities and complex integration of GenAI and LLMs challenge existing medical device regulatory frameworks, including the total product life cycle (TPLC) approach. Here we discuss the constraints of the TPLC approach to GenAI and LLM-based medical device regulation, and advocate for global collaboration in regulatory science research. This serves as the foundation for developing innovative approaches including adaptive policies and regulatory sandboxes, to test and refine governance in real-world settings. International harmonization, as seen with the International Medical Device Regulators Forum, is essential to manage implications of LLM on global health, including risks of widening health inequities driven by inherent model biases. By engaging multidisciplinary expertise, prioritizing iterative, data-driven approaches, and focusing on the needs of diverse populations, global regulatory science research enables the responsible and equitable advancement of LLM innovations in healthcare.

The rapid advancement of artificial intelligence (AI) systems in critical domains like healthcare, justice, and social services has sparked numerous regulatory initiatives aimed at ensuring their safe deployment. Current regulatory frameworks, exemplified by recent US and EU efforts, primarily focus on procedural guidelines while presuming that scientific benchmarking can effectively validate AI safety, similar to how crash tests verify vehicle safety or clinical trials validate drug efficacy. However, this approach fundamentally misunderstands the unique technical challenges posed by modern AI systems. Through systematic analysis of successful technology regulation case studies, we demonstrate that effective scientific regulation requires a causal theory linking observable test outcomes to future performance - for instance, how a vehicle's crash resistance at one speed predicts its safety at lower speeds. We show that deep learning models, which learn complex statistical patterns from training data without explicit causal mechanisms, preclude such guarantees. This limitation renders traditional regulatory approaches inadequate for ensuring AI safety. Moving forward, we call for regulators to reckon with this limitation, and propose a preliminary two-tiered regulatory framework that acknowledges these constraints: mandating human oversight for high-risk applications while developing appropriate risk communication strategies for lower-risk uses. Our findings highlight the urgent need to reconsider fundamental assumptions in AI regulation and suggest a concrete path forward for policymakers and researchers.

Protein-based therapeutics play a pivotal role in modern medicine targeting various diseases. Despite their therapeutic importance, these products can aggregate and form subvisible particles (SvPs), which can compromise their efficacy and trigger immunological responses, emphasizing the critical need for robust monitoring techniques. Flow Imaging Microscopy (FIM) has been a significant advancement in detecting SvPs, evolving from monochrome to more recently incorporating color imaging. Complementing SvP images obtained via FIM, deep learning techniques have recently been employed successfully for stress source identification of monochrome SvPs. In this study, we explore the potential of color FIM to enhance the characterization of stress sources in SvPs. To achieve this, we curate a new dataset comprising 16,000 SvPs from eight commercial monoclonal antibodies subjected to heat and mechanical stress. Using both supervised and self-supervised convolutional neural networks, as well as vision transformers in large-scale experiments, we demonstrate that deep learning with color FIM images consistently outperforms monochrome images, thus highlighting the potential of color FIM in stress source classification compared to its monochrome counterparts.

Artificial intelligence (AI) has potential to revolutionize the field of oncology by enhancing the precision of cancer diagnosis, optimizing treatment strategies, and personalizing therapies for a variety of cancers. This review examines the limitations of conventional diagnostic techniques and explores the transformative role of AI in diagnosing and treating cancers such as lung, breast, colorectal, liver, stomach, esophageal, cervical, thyroid, prostate, and skin cancers. The primary objective of this paper is to highlight the significant advancements that AI algorithms have brought to oncology within the medical industry. By enabling early cancer detection, improving diagnostic accuracy, and facilitating targeted treatment delivery, AI contributes to substantial improvements in patient outcomes. The integration of AI in medical imaging, genomic analysis, and pathology enhances diagnostic precision and introduces a novel, less invasive approach to cancer screening. This not only boosts the effectiveness of medical facilities but also reduces operational costs. The study delves into the application of AI in radiomics for detailed cancer characterization, predictive analytics for identifying associated risks, and the development of algorithm-driven robots for immediate diagnosis. Furthermore, it investigates the impact of AI on addressing healthcare challenges, particularly in underserved and remote regions. The overarching goal of this platform is to support the development of expert recommendations and to provide universal, efficient diagnostic procedures. By reviewing existing research and clinical studies, this paper underscores the pivotal role of AI in improving the overall cancer care system. It emphasizes how AI-enabled systems can enhance clinical decision-making and expand treatment options, thereby underscoring the importance of AI in advancing precision oncology

If 2023 was the year of AI fervor, following the late-2022 release of ChatGPT, 2024 was marked by a steady drumbeat of advances as systems got smarter, faster, and cheaper to run. AI also began to reason more deeply and interact via voice and video--trends that AI experts and leaders say will accelerate. Here's what to expect from AI in 2025. In 2025, we'll begin to see a shift from chatbots and image generators toward "agentic" systems that can act autonomously to complete tasks, rather than simply answer questions, says AI futurist Ray Kurzweil. In October, Anthropic gave its AI model Claude the ability to use computers--clicking, scrolling, and typing--but this may be just the start.

Molecular property prediction has attracted substantial attention recently. Accurate prediction of drug properties relies heavily on effective molecular representations. The structures of chemical compounds are commonly represented as graphs or SMILES sequences. Recent advances in learning drug properties commonly employ Graph Neural Networks (GNNs) based on the graph representation. For the SMILES representation, Transformer-based architectures have been adopted by treating each SMILES string as a sequence of tokens. Because each representation has its own advantages and disadvantages, combining both representations in learning drug properties is a promising direction. We propose a method named Dual-Modality Cross-Attention (DMCA) that can effectively combine the strengths of two representations by employing the cross-attention mechanism. DMCA was evaluated across eight datasets including both classification and regression tasks. Results show that our method achieves the best overall performance, highlighting its effectiveness in leveraging the complementary information from both graph and SMILES modalities.

Sam Berns was my friend. With the wisdom of a sage, he inspired me and many others about how to make the most of life. Afflicted with the rare disease called progeria, his body aged at a rapid rate, and he died of heart failure at just 17, a brave life cut much too short. My lab discovered the genetic cause of Sam's illness two decades ago: Just one DNA letter gone awry, a T that should have been a C in a critical gene called lamin A. The same misspelling is found in almost all of the 200 individuals around the world with progeria. This story is from the WIRED World in 2025, our annual trends briefing.

Dr. Wendy Troxel, a sleep therapist in Utah, discusses a study that found small bouts of light exercise in the evening can help promote more restful sleep. Good shut-eye is critical for all sorts of reasons -- but now there's a compelling new one, according to a study. An international team of scientists discovered an interesting incentive for getting eight hours of sleep a night. Make sure to get plenty of slumber if you're trying to learn a new language, researchers say. The study, led by the University of South Australia, revealed that the coordination of two electrical events in the sleeping brain "significantly" improves its ability to remember new words and complex grammatical rules, as news agency SWNS reported.

For the nearly 20,000 women in the U.S. who receive an ovarian cancer diagnosis each year, artificial intelligence is emerging as a potentially life-saving tool. In a new study led by researchers at Karolinska Institutet in Sweden, AI models did a better job of detecting ovarian cancer than human doctors. The research, which was published in Nature Medicine, tested an AI model's ability to distinguish between benign and malignant lesions on the ovaries, according to a press release. The AI model was trained on more than 17,000 ultrasound images from 3,652 patients across 20 hospitals in eight countries, the release stated. "High-quality diagnostics can become more accessible, particularly in regions with limited access to experienced examiners," said a study author.

Anesthetics are crucial in surgical procedures and therapeutic interventions, but they come with side effects and varying levels of effectiveness, calling for novel anesthetic agents that offer more precise and controllable effects. Targeting Gamma-aminobutyric acid (GABA) receptors, the primary inhibitory receptors in the central nervous system, could enhance their inhibitory action, potentially reducing side effects while improving the potency of anesthetics. In this study, we introduce a proteomic learning of GABA receptor-mediated anesthesia based on 24 GABA receptor subtypes by considering over 4000 proteins in protein-protein interaction (PPI) networks and over 1.5 millions known binding compounds. We develop a corresponding drug-target interaction network to identify potential lead compounds for novel anesthetic design. To ensure robust proteomic learning predictions, we curated a dataset comprising 136 targets from a pool of 980 targets within the PPI networks. We employed three machine learning algorithms, integrating advanced natural language processing (NLP) models such as pretrained transformer and autoencoder embeddings. Through a comprehensive screening process, we evaluated the side effects and repurposing potential of over 180,000 drug candidates targeting the GABRA5 receptor. Additionally, we assessed the ADMET (absorption, distribution, metabolism, excretion, and toxicity) properties of these candidates to identify those with near-optimal characteristics. This approach also involved optimizing the structures of existing anesthetics. Our work presents an innovative strategy for the development of new anesthetic drugs, optimization of anesthetic use, and deeper understanding of potential anesthesia-related side effects.