AI Medical Compendium Topic

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Device Approval

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Early access to health products in France: Major advances of the French "Conseil stratégique des industries de santé" (CSIS) to be implemented (modalities, regulations, funding).

Therapie
In a context of perpetual evolution of treatments, access to therapeutic innovation is a major challenge for patients and the various players involved in the procedures of access to medicines. The revolutions in genomic and personalized medicine, art...

Robotic surgery: new robots and finally some real competition!

World journal of urology
PURPOSE: For the last 20 years, the predominant robot used in laparoscopic surgery has been Da Vinci by Intuitive Surgical. This monopoly situation has led to rising costs and relatively slow innovation. This article aims to discuss the two new robot...

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs
Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pl...

A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior.

Clinical and translational science
Recent progress in the Internet of Things and artificial intelligence has made it possible to utilize the vast quantity of personal health records, clinical data, and scientific findings for prognosis, diagnosis, and therapy. These innovative technol...

Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.

The Lancet. Digital health
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governm...

Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence.

Korean journal of radiology
Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and p...