medical device regulators

Abstract: Artificial intelligence (AI) has several transformative effects on healthcare, like to facilitate clinicians in disease detection and to manage patient care with enhanced precision. Due to the increasing complexity of medical data and the growing volume of diagnostic images, the substantial computational power needed to process such information creates both opportunities and challenges. To accomplish this objective, numerous methodologies have been proposed to integrate AI into disease detection systems. All these methodologies consider different aspects of clinical diagnosis, considering key parameters such as the type of AI model employed, the nature of input data, and the population demographics being analysed. In this paper, we review different state-of-the-art techniques which have been proposed for various areas of disease detection, specifically focusing on bias identification and mitigation. The proposed solutions are distinguished based on the type of input data they utilize, the architecture of model, and type of bias (algorithmic bias, demographic bias, model bias, and deployment bias). The time frame chosen to filter out relevant studies is between 2015 and 2026. Eventually, we review 23 related articles out of 64,389 analyzed from seven different digital libraries. The obtained results guide us to reach a conclusion with respect to state-of-the-art selected studies. Furthermore, these results reveal significant research gaps that can assist researchers in addressing AI-related bias in medical diagnosis. By prioritizing explainability, data diversity, and fairness in algorithmic design, as well as equitable access for affected patient populations, they can utilize available healthcare resources more effectively.

Abstract: Pulmonary embolism (PE) is a leading cause of cardiovascular mortality, yet the real-world performance of FDA-cleared AI detection models remains incompletely characterized. We retrospectively evaluated two FDA-cleared AI algorithms from a single commercial platform (Aidoc Medical BriefCase), one for PE triage on dedicated CT pulmonary angiography (CTPA; n = 30,678) and one for incidental PE (iPE) detection on routine contrast-enhanced CTs (n = 37,191), across a 17-facility academic health system. Reference-standard labels were extracted from radiology reports using a validated LLM pipeline (97% accuracy, kappa = 0.94). The PE model achieved 86.8% sensitivity and 99.1% specificity, with sensitivity declining from 99.3% for saddle emboli to 72.9% for subsegmental PE, and from 89.7% for acute to 65.3% for non-acute PE. The iPE model achieved 73.5% sensitivity and 99.8% specificity. Both models demonstrated lower sensitivity than FDA-clearance benchmarks while exceeding cleared specificity, with diminishing performance for peripheral and non-acute emboli mirroring known human reader limitations and underscoring the need for standardized post-market surveillance of AI-enabled medical devices.