Mature AI/ML-Enabled Medical Tools Impacting Vascular Surgical Care: A scoping review of late-stage, FDA approved/cleared technologies relevant to vascular surgeons

Abstract

Artificial intelligence and machine learning (AI/ML)-enabled tools are shifting from theoretical or research-only applications to mature, clinically useful tools. The goal of this article was to provide a scoping review of the most mature AI/ML-enabled technologies reviewed and cleared by the US Food and Drug Administration relevant to the field of vascular surgery. Despite decades of slow progress, this landscape is now evolving rapidly, with more than 100 AI/ML-powered tools being approved by the US Food and Drug Administration each year. Within the field of vascular surgery specifically, this review identified 17 companies with mature technologies that have at least one US Food and Drug Administration clearance, all occurring between 2016 and 2022. The maturation of these technologies appears to be accelerating, with improving regulatory clarity and clinical uptake. The early AI/ML-powered devices extend or amplify clinically entrenched platform technologies and tend to be focused on the diagnosis or evaluation of time-sensitive, clinically important pathologies (eg, reading Digital Imaging and Communications in Medicine-compliant computed tomography images to identify pulmonary embolism), or when physician efficiency or time savings is improved (eg, preoperative planning and intraoperative guidance). The majority (>75%) of these technologies are at the intersection of radiology and vascular surgery. It is becoming increasingly important that the contemporary vascular surgeon understands this shifting paradigm, as these once-nascent technologies are finally maturing and will be encountered with increasingly regularity in daily clinical practice.