arXiv:2407. 11823v4 Announce Type: replace Abstract: The United States Food and Drug Administration's (FDA's) 510(k) pathway allows manufacturers to gain medical device approval by demonstrating substantial equivalence to a legally marketed device.
arXiv:2608. 12360v1 Announce Type: cross Abstract: Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks.
arXiv:2606. 27174v1 Announce Type: new Abstract: Medical device recalls are a critical regulatory mechanism for protecting patient safety.
Medical device recalls are a critical regulatory mechanism for protecting patient safety. The growing volume of FDA recall records presents challenges in post-report recall triage, severity assessment, and root-cause interpretation.
arXiv:2606. 28353v1 Announce Type: cross Abstract: Linking FDA-approved medical devices to their underlying United States Patent and Trademark Office (USPTO) patents enables critical applications such as recall root-cause analysis, M&A-driven IP discovery, and technology trajectory mapping.
arXiv:2509. 08604v5 Announce Type: replace-cross Abstract: Large Language Models (LLMs) have demonstrated significant potential in medicine, with many studies adapting them through continued pre-training or fine-tuning on medical data to enhance domain-specific accuracy and safety.
arXiv:2607. 20542v1 Announce Type: cross Abstract: A critical challenge in healthcare systems in low- and middle-income countries (LMICs) is the efficient and equitable allocation of scarce resources, particularly essential medicines.
arXiv:2505. 16941v4 Announce Type: replace-cross Abstract: Foundation models (FMs) promise to address core limitations of traditional supervised machine learning: (i) reliance on large amounts of labeled data, (ii) task specificity, and (iii) poor transportability.
arXiv:2606. 07141v1 Announce Type: cross Abstract: Language models trained for clinical disease inference are trained on patient data, which may include sensitive and private information, and data owners may request the removal of their data from a trained model due to privacy or copyright concerns.
arXiv:2606. 14149v1 Announce Type: new Abstract: Large Language Models (LLMs) are increasingly deployed in healthcare settings, yet their tendency to hallucinate poses risks when clinical decisions are involved.
arXiv:2608. 03511v1 Announce Type: cross Abstract: Active learning (AL) promises to reduce the cost of medical imaging projects by lowering the number of clinical labels required.
arXiv:2606. 28692v1 Announce Type: new Abstract: Treatment reasoning underpins every therapeutic decision, integrating disease context, comorbidities, medications, contraindications, and evolving biomedical knowledge to select an appropriate therapy.
arXiv:2607. 29090v1 Announce Type: new Abstract: Postoperative adverse events, including mortality and morbidity, remain a major global burden, many of which are preventable through early identification of high-risk patients and targeted perioperative care.