Artificial Intelligence-Enabled Medical Devices in Orthopedics and Cardiology: A Review of Current Applications and Regulatory Landscape

Abstract

Future medical equipment is being gradually shaped by artificial intelligence, which offers accuracy, personalization, and efficiency in healthcare. By improving patient outcomes and enhancing surgical and diagnostic precision, artificial intelligence (AI) is transforming orthopedic bio-engineering. This review focusses on the application of AI in orthopedics to bone-regeneration devices, smart implants, intraoperative robotics, and preoperative planning. Orthopedic practices have undergone a significant transformation due to robotic-assisted surgery, AI-powered imaging, and automated 3D anatomical modelling. Orthopedic AI developments are exciting, but there are still issues to be resolved, such as the requirement for standardized validation procedures, the moral implications of AI-generated judgement, and real-world implementation in clinical settings. Cardiovascular medicine is using AI technologies more and more, which hold promise for better diagnosis, prognostic modelling and care personalization. Wearable technology for the detection of malignant arrhythmias, non-invasive coronary artery disease diagnosis, precise cardiovascular outcome prediction, and customized treatment for patients with heart failure are all made possible by artificial intelligence. However, there are still many obstacles to overcome, including data privacy, legal frameworks, clinical workflow integration, algorithm transparency, and real-world validation. These issues also help clinicians in emergency situations by providing prompt risk assessments and decision support. In addition to these, AI medical devices are employed in radiological imaging, ophthalmology analysis, and dental diagnostics for patient care. Overall, this review concludes that AI-driven advancements in orthopedic and cardiology devices are a major step towards precision medicine, improving patient care outcomes, safety, and efficiency while highlighting the continued need for clinical validation and ethical supervision.