Related papers: FDA AI Search: Making FDA-Authorized AI Devices Se…

Screening patients for clinical trial eligibility remains a manual, time-consuming, and resource-intensive process. We present a secure, scalable proof-of-concept system for Artificial Intelligence (AI)-augmented patient-trial matching that…

Artificial Intelligence (AI) and Machine-Learning (ML) models have been increasingly used in medical products, such as medical device software. General considerations on the statistical aspects for the evaluation of AI/ML-enabled medical…

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…

Observers and practitioners of artificial intelligence (AI) have proposed an FDA-style licensing regime for the most advanced AI models, or 'frontier' models. In this paper, we explore the applicability of approval regulation -- that is,…

This paper proposes a possible method using natural language processing that might assist in the FDA medical device marketing process. Actual device descriptions are taken and matched with the device description in FDA Title 21 of CFR to…

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. However, the inherent ambiguity of this…

Remarkable success of modern image-based AI methods and the resulting interest in their applications in critical decision-making processes has led to a surge in efforts to make such intelligent systems transparent and explainable. The need…

There is a growing demand for the use of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare, particularly as clinical decision support systems to assist medical professionals. However, the complexity of many of these…

Drug discovery is adapting to novel technologies such as data science, informatics, and artificial intelligence (AI) to accelerate effective treatment development while reducing costs and animal experiments. AI is transforming drug…

Artificial intelligence (AI) is transforming the practice of science. Machine learning and large language models (LLMs) can generate hypotheses at a scale and speed far exceeding traditional methods, offering the potential to accelerate…

Artificial intelligence (AI) has been transforming the practice of drug discovery in the past decade. Various AI techniques have been used in a wide range of applications, such as virtual screening and drug design. In this survey, we first…

Purpose: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD),…

Artificial intelligence (AI) in medical device software (MDSW) represents a transformative clinical technology, attracting increasing attention within both the medical community and the regulators. In this study, we leverage a data-driven…

Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…

Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in…

Multimodal artificial intelligence (AI) systems have the potential to enhance clinical decision-making by interpreting various types of medical data. However, the effectiveness of these models across all medical fields is uncertain. Each…

Patient recruitment remains a major bottleneck in clinical trials, calling for scalable and automated solutions. We present TrialMatchAI, an AI-powered recommendation system that automates patient-to-trial matching by processing…

Recent advancements in artificial intelligence (AI) and its widespread integration into mobile software applications have received significant attention, highlighting the growing prominence of AI capabilities in modern software systems.…

In low- and middle-income countries (LMICs), a significant proportion of medical diagnostic equipment remains underutilized or non-functional due to a lack of timely maintenance, limited access to technical expertise, and minimal support…

The recent spike in certified Artificial Intelligence (AI) tools for healthcare has renewed the debate around adoption of this technology. One thread of such debate concerns Explainable AI and its promise to render AI devices more…