The news: A bill that allows clinics to sell unproven treatments has been passed in Montana. Under the legislation, doctors can apply for a license to open an experimental treatment clinic and recommend and sell therapies not approved by the Food and Drug Administration (FDA) to their patients. Why it matters: Once it's signed by the governor, the law will be the most expansive in the country in allowing access to drugs that have not been fully tested. The bill allows for any drug produced in the state to be sold in it, providing it has been through phase I clinical trials--but these trials do not determine if the drug is effective. The big picture: The bill was drafted and lobbied for by people interested in extending human lifespans.

Surgeries may become safer and more precise than ever before. A French startup named Robeauté has just raised about 29 million to develop a truly groundbreaking neurosurgical microrobot. Imagine a device no bigger than a grain of rice that can carefully navigate the complex and delicate pathways of the brain. This little robot could change the way doctors treat brain tumors and other neurological conditions, making surgeries safer and more precise than ever before. Join The FREE CyberGuy Report: Get my expert tech tips, critical security alerts, and exclusive deals -- plus instant access to my free Ultimate Scam Survival Guide when you sign up! Brain surgery is incredibly complex.

The medical device industry has significantly advanced by integrating sophisticated electronics like microchips and field-programmable gate arrays (FPGAs) to enhance the safety and usability of life-saving devices. These complex electro-mechanical systems, however, introduce challenging failure modes that are not easily detectable with conventional methods. Effective fault detection and mitigation become vital as reliance on such electronics grows. This paper explores three generative machine learning-based approaches for fault detection in medical devices, leveraging sensor data from surgical staplers,a class 2 medical device. Historically considered low-risk, these devices have recently been linked to an increasing number of injuries and fatalities. The study evaluates the performance and data requirements of these machine-learning approaches, highlighting their potential to enhance device safety.

The Food and Drug Administration has been meeting with OpenAI to discuss the agency's use of AI, according to sources with knowledge of the meetings. The meetings appear to be part of a broader effort at the FDA to use this technology to speed up the drug approval process. "Why does it take over 10 years for a new drug to come to market?" "Why are we not modernized with AI and other things? We've just completed our first AI-assisted scientific review for a product and that's just the beginning."

Recently, a growing number of experts in artificial intelligence (AI) and medicine have be-gun to suggest that the use of AI systems, particularly machine learning (ML) systems, is likely to humanise the practice of medicine by substantially improving the quality of clinician-patient relationships. In this thesis, however, I argue that medical ML systems are more likely to negatively impact these relationships than to improve them. In particular, I argue that the use of medical ML systems is likely to comprise the quality of trust, care, empathy, understanding, and communication between clinicians and patients.

Dr. Marty Makary pointed out the Biden administration's decision to skip key committee meetings when authorizing vaccines in response to a top Democrat's question. FIRST ON FOX -- The Food and Drug Administration is phasing out an animal testing requirement for antibody therapies and other drugs in favor of testing on materials that mimic human organs, the FDA announced on Thursday. "For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use," FDA Commissioner Martin A. Makary, said in comment provided to Fox News Digital. "By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics."

Social media is a rich source of real-world data that captures valuable patient experience information for pharmacovigilance. However, mining data from unstructured and noisy social media content remains a challenging task. We present a systematic framework that leverages large language models (LLMs) to extract medication side effects from social media and organize them into a knowledge graph (KG). We apply this framework to semaglutide for weight loss using data from Reddit. Using the constructed knowledge graph, we perform comprehensive analyses to investigate reported side effects across different semaglutide brands over time. These findings are further validated through comparison with adverse events reported in the FAERS database, providing important patient-centered insights into semaglutide's side effects that complement its safety profile and current knowledge base of semaglutide for both healthcare professionals and patients. Our work demonstrates the feasibility of using LLMs to transform social media data into structured KGs for pharmacovigilance.

It is commonly accepted that clinicians are ethically obligated to disclose their use of medical machine learning systems to patients, and that failure to do so would amount to a moral fault for which clinicians ought to be held accountable. Call this "the disclosure thesis." Four main arguments have been, or could be, given to support the disclosure thesis in the ethics literature: the risk-based argument, the rights-based argument, the materiality argument, and the autonomy argument. In this article, I argue that each of these four arguments are unconvincing, and therefore, that the disclosure thesis ought to be rejected. I suggest that mandating disclosure may also even risk harming patients by providing stakeholders with a way to avoid accountability for harm that results from improper applications or uses of these systems.

A new benchmark dataset for functional data analysis (FDA) is presented, focusing on the reconstruction of eye movements from EEG data. The contribution is twofold: first, open challenges and evaluation metrics tailored to FDA applications are proposed. Second, functional neural networks are used to establish baseline results for the primary regression task of reconstructing eye movements from EEG signals. Baseline results are reported for the new dataset, based on consumer-grade hardware, and the EEGEyeNet dataset, based on research-grade hardware.

Leveraging large language models (LLMs) to generate high-stakes documents, such as informed consent forms (ICFs), remains a significant challenge due to the extreme need for regulatory compliance and factual accuracy. Here, we present InformGen, an LLM-driven copilot for accurate and compliant ICF drafting by optimized knowledge document parsing and content generation, with humans in the loop. We further construct a benchmark dataset comprising protocols and ICFs from 900 clinical trials. Experimental results demonstrate that InformGen achieves near 100% compliance with 18 core regulatory rules derived from FDA guidelines, outperforming a vanilla GPT-4o model by up to 30%. Additionally, a user study with five annotators shows that InformGen, when integrated with manual intervention, attains over 90% factual accuracy, significantly surpassing the vanilla GPT-4o model's 57%-82%. Crucially, InformGen ensures traceability by providing inline citations to source protocols, enabling easy verification and maintaining the highest standards of factual integrity.