Neuralink's brain chip has been implanted into a second patient as part of early human trials, Elon Musk told podcast host Lex Fridman on Saturday. The company hasn't disclosed when the surgery took place or the name of the recipient, according to Reuters. Musk said 400 of the electrodes on the second patient's brain are working out of 1,024 implanted. "I don't want to jinx it but it seems to have gone extremely well," he said. The device allows patients with spinal cord injuries to play video games, use the internet and control electronic devices using their thoughts alone.

The validity of medical studies based on real-world clinical data, such as observational studies, depends on critical assumptions necessary for drawing causal conclusions about medical interventions. Many published studies are flawed because they violate these assumptions and entail biases such as residual confounding, selection bias, and misalignment between treatment and measurement times. Although researchers are aware of these pitfalls, they continue to occur because anticipating and addressing them in the context of a specific study can be challenging without a large, often unwieldy, interdisciplinary team with extensive expertise. To address this expertise gap, we explore the use of large language models (LLMs) as co-pilot tools to assist researchers in identifying study design flaws that undermine the validity of causal inferences. We propose a conceptual framework for LLMs as causal co-pilots that encode domain knowledge across various fields, engaging with researchers in natural language interactions to provide contextualized assistance in study design. We provide illustrative examples of how LLMs can function as causal co-pilots, propose a structured framework for their grounding in existing causal inference frameworks, and highlight the unique challenges and opportunities in adapting LLMs for reliable use in epidemiological research.

The United States Food and Drug Administration's (FDA's) Premarket Notification 510(K) pathway allows manufacturers to gain approval for a medical device by demonstrating its substantial equivalence to another legally marketed device. However, the inherent ambiguity of this regulatory procedure has led to high recall rates for many devices cleared through this pathway. This trend has raised significant concerns regarding the efficacy of the FDA's current approach, prompting a reassessment of the 510(K) regulatory framework. In this paper, we develop a combined human-algorithm approach to assist the FDA in improving its 510(k) medical device clearance process by reducing the risk of potential recalls and the workload imposed on the FDA. We first develop machine learning methods to estimate the risk of recall of 510(k) medical devices based on the information available at the time of submission. We then propose a data-driven clearance policy that recommends acceptance, rejection, or deferral to FDA's committees for in-depth evaluation. We conduct an empirical study using a unique large-scale dataset of over 31,000 medical devices and 12,000 national and international manufacturers from over 65 countries that we assembled based on data sources from the FDA and Centers for Medicare and Medicaid Service (CMS). A conservative evaluation of our proposed policy based on this data shows a 38.9% improvement in the recall rate and a 43.0% reduction in the FDA's workload. Our analyses also indicate that implementing our policy could result in significant annual cost-savings ranging between \$2.4 billion and \$2.7 billion, which highlights the value of using a holistic and data-driven approach to improve the FDA's current 510(K) medical device evaluation pathway.

As more clinical workflows continue to be augmented by artificial intelligence (AI), AI literacy among physicians will become a critical requirement for ensuring safe and ethical AI-enabled patient care. Despite the evolving importance of AI in healthcare, the extent to which it has been adopted into traditional and often-overloaded medical curricula is currently unknown. In a scoping review of 1,699 articles published between January 2016 and June 2024, we identified 18 studies which propose guiding frameworks, and 11 studies documenting real-world instruction, centered around the integration of AI into medical education. We found that comprehensive guidelines will require greater clinical relevance and personalization to suit medical student interests and career trajectories. Current efforts highlight discrepancies in the teaching guidelines, emphasizing AI evaluation and ethics over technical topics such as data science and coding. Additionally, we identified several challenges associated with integrating AI training into the medical education program, including a lack of guidelines to define medical students AI literacy, a perceived lack of proven clinical value, and a scarcity of qualified instructors. With this knowledge, we propose an AI literacy framework to define competencies for medical students. To prioritize relevant and personalized AI education, we categorize literacy into four dimensions: Foundational, Practical, Experimental, and Ethical, with tailored learning objectives to the pre-clinical, clinical, and clinical research stages of medical education. This review provides a road map for developing practical and relevant education strategies for building an AI-competent healthcare workforce.

Significant interests have recently risen in leveraging sequence-based large language models (LLMs) for drug design. However, most current applications of LLMs in drug discovery lack the ability to comprehend three-dimensional (3D) structures, thereby limiting their effectiveness in tasks that explicitly involve molecular conformations. In this study, we introduced Token-Mol, a token-only 3D drug design model. This model encodes all molecular information, including 2D and 3D structures, as well as molecular property data, into tokens, which transforms classification and regression tasks in drug discovery into probabilistic prediction problems, thereby enabling learning through a unified paradigm. Token-Mol is built on the transformer decoder architecture and trained using random causal masking techniques. Additionally, we proposed the Gaussian cross-entropy (GCE) loss function to overcome the challenges in regression tasks, significantly enhancing the capacity of LLMs to learn continuous numerical values. Through a combination of fine-tuning and reinforcement learning (RL), Token-Mol achieves performance comparable to or surpassing existing task-specific methods across various downstream tasks, including pocket-based molecular generation, conformation generation, and molecular property prediction. Compared to existing molecular pre-trained models, Token-Mol exhibits superior proficiency in handling a wider range of downstream tasks essential for drug design. Notably, our approach improves regression task accuracy by approximately 30% compared to similar token-only methods. Token-Mol overcomes the precision limitations of token-only models and has the potential to integrate seamlessly with general models such as ChatGPT, paving the way for the development of a universal artificial intelligence drug design model that facilitates rapid and high-quality drug design by experts.

We applied machine learning to the unmet medical need of rapid and accurate diagnosis and prognosis of acute infections and sepsis in emergency departments. Our solution consists of a Myrna (TM) Instrument and embedded TriVerity (TM) classifiers. The instrument measures abundances of 29 messenger RNAs in patient's blood, subsequently used as features for machine learning. The classifiers convert the input features to an intuitive test report comprising the separate likelihoods of (1) a bacterial infection (2) a viral infection, and (3) severity (need for Intensive Care Unit-level care). In internal validation, the system achieved AUROC = 0.83 on the three-class disease diagnosis (bacterial, viral, or non-infected) and AUROC = 0.77 on binary prognosis of disease severity. The Myrna, TriVerity system was granted breakthrough device designation by the United States Food and Drug Administration (FDA). This engineering manuscript teaches the standard and novel machine learning methods used to translate an academic research concept to a clinical product aimed at improving patient care, and discusses lessons learned.

The development of magnetic resonance imaging (MRI) for medical imaging has provided a leap forward in diagnosis, providing a safe, non-invasive alternative to techniques involving ionising radiation exposure for diagnostic purposes. It was described by Block and Purcel in 1946, and it was not until 1980 that the first clinical application of MRI became available. Since that time the MRI has gone through many advances and has altered the way diagnosing procedures are performed. Due to its ability to improve constantly, MRI has become a commonly used practice among several specialisations in medicine. Particularly starting 0.55T and 7T MRI technologies have pointed out enhanced preservation of image detail and advanced tissue characterisation. This review examines the integration of deep learning (DL) techniques into these MRI modalities, disseminating and exploring the study applications. It highlights how DL contributes to 0.55T and 7T MRI data, showcasing the potential of DL in improving and refining these technologies. The review ends with a brief overview of how MRI technology will evolve in the coming years.

The objective of this research is to introduce a network specialized in predicting drugs that can be repurposed by investigating real-world evidence sources, such as clinical trials and biomedical literature. Specifically, it aims to generate drug combination therapies for complex diseases (e.g., cancer, Alzheimer's). We present a multilayered network medicine approach, empowered by a highly configured ChatGPT prompt engineering system, which is constructed on the fly to extract drug mentions in clinical trials. Additionally, we introduce a novel algorithm that connects real-world evidence with disease-specific signaling pathways (e.g., KEGG database). This sheds light on the repurposability of drugs if they are found to bind with one or more protein constituents of a signaling pathway. To demonstrate, we instantiated the framework for breast cancer and found that, out of 46 breast cancer signaling pathways, the framework identified 38 pathways that were covered by at least two drugs. This evidence signals the potential for combining those drugs. Specifically, the most covered signaling pathway, ID hsa:2064, was covered by 108 drugs, some of which can be combined. Conversely, the signaling pathway ID hsa:1499 was covered by only two drugs, indicating a significant gap for further research. Our network medicine framework, empowered by GenAI, shows promise in identifying drug combinations with a high degree of specificity, knowing the exact signaling pathways and proteins that serve as targets. It is noteworthy that ChatGPT successfully accelerated the process of identifying drug mentions in clinical trials, though further investigations are required to determine the relationships among the drug mentions.

Generative AI (GenAI) models have demonstrated remarkable capabilities in a wide variety of medical tasks. However, as these models are trained using generalist datasets with very limited human oversight, they can learn uses of medical products that have not been adequately evaluated for safety and efficacy, nor approved by regulatory agencies. Given the scale at which GenAI may reach users, unvetted recommendations pose a public health risk. In this work, we propose an approach to identify potentially harmful product recommendations, and demonstrate it using a recent multimodal large language model.

While the pace of development of AI has rapidly progressed in recent years, the implementation of safe and effective regulatory frameworks has lagged behind. In particular, the adaptive nature of AI models presents unique challenges to regulators as updating a model can improve its performance but also introduce safety risks. In the US, the Food and Drug Administration (FDA) has been a forerunner in regulating and approving hundreds of AI medical devices. To better understand how AI is updated and its regulatory considerations, we systematically analyze the frequency and nature of updates in FDA-approved AI medical devices. We find that less than 2% of all devices report having been updated by being re-trained on new data. Meanwhile, nearly a quarter of devices report updates in the form of new functionality and marketing claims. As an illustrative case study, we analyze pneumothorax detection models and find that while model performance can degrade by as much as 0.18 AUC when evaluated on new sites, re-training on site-specific data can mitigate this performance drop, recovering up to 0.23 AUC. However, we also observed significant degradation on the original site after re-training using data from new sites, providing insight from one example that challenges the current one-model-fits-all approach to regulatory approvals. Our analysis provides an in-depth look at the current state of FDA-approved AI device updates and insights for future regulatory policies toward model updating and adaptive AI.