AI Medical Compendium Journal:
Expert review of medical devices

Showing 11 to 20 of 38 articles

Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.

Expert review of medical devices
INTRODUCTION: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Robotic navigation during spine surgery: an update of literature.

Expert review of medical devices
INTRODUCTION: The application of robotic navigation during spine surgery has advanced rapidly over the past two decades, especially in the last 5 years. Robotic systems in spine surgery may offer potential advantages for both patients and surgeons. T...

A review of arrhythmia detection based on electrocardiogram with artificial intelligence.

Expert review of medical devices
INTRODUCTION: With the widespread availability of portable electrocardiogram (ECG) devices, there will be a surge in ECG diagnoses. Traditional computer-aided diagnosis of arrhythmia mainly relies on the rules of medical knowledge, which are insuffic...

Rehabilitation robotics after stroke: a bibliometric literature review.

Expert review of medical devices
INTRODUCTION: Stroke is the leading cause of long-term disability in developed countries. Due to population aging, the number of people requiring rehabilitation after stroke is going to rise in the coming decades. Robot-mediated neurorehabilitation h...

The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software.

Expert review of medical devices
INTRODUCTION: Artificial Intelligence (AI) is becoming increasingly utilized in the medical device industry as it can address unmet demands in clinical sites and provide more patient treatment options. This study aims to analyze the FDA's Breakthroug...

A comparative study of regulatory perspectives on innovative medical devices in Korea and the United States.

Expert review of medical devices
INTRODUCTION: As the 4th Industrial Revolution era emerges, medical devices that apply technologies such as big data, artificial intelligence, and 3D printers are on the rise. In April 2019, Korea introduced the Act on Nurturing Medical Devices Indus...

Artificially intelligent chatbots in digital mental health interventions: a review.

Expert review of medical devices
INTRODUCTION: Increasing demand for mental health services and the expanding capabilities of artificial intelligence (AI) in recent years has driven the development of digital mental health interventions (DMHIs). To date, AI-based chatbots have been ...

Lung detection and severity prediction of pneumonia patients based on COVID-19 DET-PRE network.

Expert review of medical devices
BACKGROUND: The sudden outbreak of COVID-19 pneumonia has brought a heavy disaster to individuals globally. Facing this new virus, the clinicians have no automatic tools to assess the severity of pneumonia patients.

A review on patient-specific facial and cranial implant design using Artificial Intelligence (AI) techniques.

Expert review of medical devices
INTRODUCTION: Researchers and engineers have found their importance in healthcare industry including recent updates in patient-specific implant (PSI) design. CAD/CAM technology plays an important role in the design and development of Artificial Intel...

The role of robotic technology in minimally invasive surgery for mitral valve disease.

Expert review of medical devices
INTRODUCTION: Robotic mitral valve surgery has developed for more than 20 years. The main purpose of robotic assistance is to use multiwristed instruments for surgical endothoracic maneuvers on the mitral valve without opening the chest. The surgeon ...