FDA
Grotesque model reveals what the average sedentary person could look like by 2050 - with sunken eyes, bald spots, and 'tech neck'
Distraught illegal migrant shrieks'Help me, I have my papers' as she is arrested by ICE at Salt Lake City airport Hotly-anticipated JonBenet Ramsey drama starring Melissa McCarthy and Clive Owen'will NEVER see the light of day' US plans to BOMB Venezuela as Trump's war hawks brand Maduro'al-Qaeda of the West' Royal insiders tell me Andrew is just the start... and reveal the'bigger unravelling coming next': MAUREEN CALLAHAN Do you have a limited group of close friends, enjoy time alone and find parties draining? You may have a newly discovered rare personality type... take our test to find out We lost 100 lbs without taking'easy way out' Ozempic by using these'traditional' methods: They're simple daily habits... that ended our 1,000-calorie donuts binges for good'I don't think it's all over for Andrew': Mr Mountbatten Windsor's humiliation opens the door for full POLICE probe, royal biographer says - ex-Prince starts first day as a commoner by preparing for eviction from Royal Lodge NORMAN BAKER: Andrew's banishment is a desperate attempt to insulate the monarchy from the far BIGGER scandal everyone's missed. Charles knows the genie's out of the bottle - but it's too late What will happen next for Princesses Beatrice and Eugenie and their royal titles revealed - as both flee the country amid Andrew's final humiliation Airport towers fall eerily silent amid controller crisis as government shutdown drives $4.2B tourism loss for US economy: Live updates FDA warns dentists and parents not to give fluoride to children... as substance is linked to'broad health implications' Devastating new poll shows NYC's socialist mayoral hopeful Zohran Mamdani has opened 25 point lead over centrist Democrat rival Pearl-wearing son of top lawyer'rammed cops in Mercedes G-Wagon'... read the full shocking allegations now set to sully his family's name Total meltdown at CBS as anti-woke new boss Bari Weiss deploys shock and awe tactics: Staff are'running scared'... as insiders reveal what they fear most Actor with towering 7ft stature who starred in iconic Halloween films is seen in LA... can you guess who? It's Meghan's festive fare - with sprinkles of Highgrove! Duchess reveals first Christmas range with startling similarities to the King's Fired CBS News producer claims only'people of color' were booted - and that white co-workers were allowed to transfer elsewhere Grotesque model reveals what the average sedentary person could look like by 2050 - with sunken eyes, bald spots, and'tech neck' Today's culture of convenience means it's easy to order food, take work meetings and connect with friends while sitting on the sofa.
Statistically Valid Post-Deployment Monitoring Should Be Standard for AI-Based Digital Health
Dolin, Pavel, Li, Weizhi, Dasarathy, Gautam, Berisha, Visar
This position paper argues that post-deployment monitoring in clinical AI is underdeveloped and proposes statistically valid and label-efficient testing frameworks as a principled foundation for ensuring reliability and safety in real-world deployment. A recent review found that only 9% of FDA-registered AI-based healthcare tools include a post-deployment surveillance plan. Existing monitoring approaches are often manual, sporadic, and reactive, making them ill-suited for the dynamic environments in which clinical models operate. We contend that post-deployment monitoring should be grounded in label-efficient and statistically valid testing frameworks, offering a principled alternative to current practices. We use the term "statistically valid" to refer to methods that provide explicit guarantees on error rates (e.g., Type I/II error), enable formal inference under pre-defined assumptions, and support reproducibility--features that align with regulatory requirements. Specifically, we propose that the detection of changes in the data and model performance degradation should be framed as distinct statistical hypothesis testing problems. Grounding monitoring in statistical rigor ensures a reproducible and scientifically sound basis for maintaining the reliability of clinical AI systems. Importantly, it also opens new research directions for the technical community--spanning theory, methods, and tools for statistically principled detection, attribution, and mitigation of post-deployment model failures in real-world settings.
Transforming Multi-Omics Integration with GANs: Applications in Alzheimer's and Cancer
Reza, Md Selim, Afroz, Sabrin, Rahman, Mostafizer, Alam, Md Ashad
Multi-omics data integration is crucial for understanding complex diseases, yet limited sample sizes, noise, and heterogeneity often reduce predictive power. To address these challenges, we introduce Omics-GAN, a Generative Adversarial Network (GAN)-based framework designed to generate high-quality synthetic multi-omics profiles while preserving biological relationships. We evaluated Omics-GAN on three omics types (mRNA, miRNA, and DNA methylation) using the ROSMAP cohort for Alzheimer's disease (AD) and TCGA datasets for colon and liver cancer. A support vector machine (SVM) classifier with repeated 5-fold cross-validation demonstrated that synthetic datasets consistently improved prediction accuracy compared to original omics profiles. The AUC of SVM for mRNA improved from 0.72 to 0.74 in AD, and from 0.68 to 0.72 in liver cancer. Synthetic miRNA enhanced classification in colon cancer from 0.59 to 0.69, while synthetic methylation data improved performance in liver cancer from 0.64 to 0.71. Boxplot analyses confirmed that synthetic data preserved statistical distributions while reducing noise and outliers. Feature selection identified significant genes overlapping with original datasets and revealed additional candidates validated by GO and KEGG enrichment analyses. Finally, molecular docking highlighted potential drug repurposing candidates, including Nilotinib for AD, Atovaquone for liver cancer, and Tecovirimat for colon cancer. Omics-GAN enhances disease prediction, preserves biological fidelity, and accelerates biomarker and drug discovery, offering a scalable strategy for precision medicine applications.
Job titles of the future: AI embryologist
Scientists are using AI to better predict embryo health in real time. Embryologists are the scientists behind the scenes of in vitro fertilization who oversee the development and selection of embryos, prepare them for transfer, and maintain the lab environment. They've been a critical part of IVF for decades, but their job has gotten a whole lot busier in recent years as demand for the fertility treatment skyrockets and clinics struggle to keep up. The United States is in fact facing a critical shortage of both embryologists and genetic counselors. Klaus Wiemer, a veteran embryologist and IVF lab director, believes artificial intelligence might help by predicting embryo health in real time and unlocking new avenues for productivity in the lab. Wiemer is the chief scientific officer and head of clinical affairs at Fairtility, a company that uses artificial intelligence to shed light on the viability of eggs and embryos before proceeding with IVF.
A bionic knee restores natural movement
In a small clinical study, people with above-the-knee amputations said it helped them navigate more easily and felt more like part of their body. A subject with the osseointegrated mechanoneural prosthesis overcomes an obstacle placed in their walking path by volitionally flexing and extending their phantom knee joint. Control signals from their residual knee muscles are used to produce movement of the powered prosthetic knee that mirrors the phantom knee. MIT researchers have developed a new bionic knee that is integrated directly with the user's muscle and bone tissue. It can help people with above-the-knee amputations walk faster, climb stairs, and avoid obstacles more easily than they could with a traditional prosthesis, which is attached to the residual limb by means of a socket and can be uncomfortable. For several years, Hugh Herr, SM '93, co-director of the K. Lisa Yang Center for Bionics, has been working with his colleagues on techniques that can extract neural information from muscles left behind after an amputation and use that information to help guide a prosthetic limb.
ReclAIm: A multi-agent framework for degradation-aware performance tuning of medical imaging AI
Tzanis, Eleftherios, Klontzas, Michail E.
Ensuring the long-term reliability of AI models in clinical practice requires continuous performance monitoring and corrective actions when degradation occurs. Addressing this need, this manuscript presents ReclAIm, a multi-agent framework capable of autonomously monitoring, evaluating, and fine-tuning medical image classification models. The system, built on a large language model core, operates entirely through natural language interaction, eliminating the need for programming expertise. ReclAIm successfully trains, evaluates, and maintains consistent performance of models across MRI, CT, and X-ray datasets. Once ReclAIm detects significant performance degradation, it autonomously executes state-of-the-art fine-tuning procedures that substantially reduce the performance gap. In cases with performance drops of up to -41.1% (MRI InceptionV3), ReclAIm managed to readjust performance metrics within 1.5% of the initial model results. ReclAIm enables automated, continuous maintenance of medical imaging AI models in a user-friendly and adaptable manner that facilitates broader adoption in both research and clinical environments.
Real-Time Surgical Instrument Defect Detection via Non-Destructive Testing
Ain, Qurrat Ul, Jilani, Atif Aftab Ahmed, Shafqat, Zunaira, Butt, Nigar Azhar
Defective surgical instruments pose serious risks to sterility, mechanical integrity, and patient safety, increasing the likelihood of surgical complications. However, quality control in surgical instrument manufacturing often relies on manual inspection, which is prone to human error and inconsistency. This study introduces SurgScan, an AI-powered defect detection framework for surgical instruments. Using YOLOv8, SurgScan classifies defects in real-time, ensuring high accuracy and industrial scalability. The model is trained on a high-resolution dataset of 102,876 images, covering 11 instrument types and five major defect categories. Extensive evaluation against state-of-the-art CNN architectures confirms that SurgScan achieves the highest accuracy (99.3%) with real-time inference speeds of 4.2-5.8 ms per image, making it suitable for industrial deployment. Statistical analysis demonstrates that contrast-enhanced preprocessing significantly improves defect detection, addressing key limitations in visual inspection. SurgScan provides a scalable, cost-effective AI solution for automated quality control, reducing reliance on manual inspection while ensuring compliance with ISO 13485 and FDA standards, paving the way for enhanced defect detection in medical manufacturing.
Robust or Suggestible? Exploring Non-Clinical Induction in LLM Drug-Safety Decisions
Liu, Siying, Zhang, Shisheng, Bala, Indu
Large language models (LLMs) are increasingly applied in biomedical domains, yet their reliability in drug-safety prediction remains underexplored. In this work, we investigate whether LLMs incorporate socio-demographic information into adverse event (AE) predictions, despite such attributes being clinically irrelevant. Using structured data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and a persona-based evaluation framework, we assess two state-of-the-art models, ChatGPT-4o and Bio-Medical-Llama-3.8B, across diverse personas defined by education, marital status, employment, insurance, language, housing stability, and religion. We further evaluate performance across three user roles (general practitioner, specialist, patient) to reflect real-world deployment scenarios where commercial systems often differentiate access by user type. Our results reveal systematic disparities in AE prediction accuracy. Disadvantaged groups (e.g., low education, unstable housing) were frequently assigned higher predicted AE likelihoods than more privileged groups (e.g., postgraduate-educated, privately insured). Beyond outcome disparities, we identify two distinct modes of bias: explicit bias, where incorrect predictions directly reference persona attributes in reasoning traces, and implicit bias, where predictions are inconsistent, yet personas are not explicitly mentioned. These findings expose critical risks in applying LLMs to pharmacovigilance and highlight the urgent need for fairness-aware evaluation protocols and mitigation strategies before clinical deployment.
CGBench: Benchmarking Language Model Scientific Reasoning for Clinical Genetics Research
Queen, Owen, Zhang, Harrison G., Zou, James
Variant and gene interpretation are fundamental to personalized medicine and translational biomedicine. However, traditional approaches are manual and labor-intensive. Generative language models (LMs) can facilitate this process, accelerating the translation of fundamental research into clinically-actionable insights. While existing benchmarks have attempted to quantify the capabilities of LMs for interpreting scientific data, these studies focus on narrow tasks that do not translate to real-world research. To meet these challenges, we introduce CGBench, a robust benchmark that tests reasoning capabilities of LMs on scientific publications. CGBench is built from ClinGen, a resource of expert-curated literature interpretations in clinical genetics. CGBench measures the ability to 1) extract relevant experimental results following precise protocols and guidelines, 2) judge the strength of evidence, and 3) categorize and describe the relevant outcome of experiments. We test 8 different LMs and find that while models show promise, substantial gaps exist in literature interpretation, especially on fine-grained instructions. Reasoning models excel in fine-grained tasks but non-reasoning models are better at high-level interpretations. Finally, we measure LM explanations against human explanations with an LM judge approach, revealing that models often hallucinate or misinterpret results even when correctly classifying evidence. CGBench reveals strengths and weaknesses of LMs for precise interpretation of scientific publications, opening avenues for future research in AI for clinical genetics and science more broadly.