A Scoping Review of Artificial Intelligence as a Medical Device for Ophthalmic Image Analysis in Europe, Australia and America

A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America

This scoping review aims to identify regulator-approved ophthalmic image analysis artificial intelligence as a medical device (AIaMD) in three jurisdictions, examine their characteristics and regulatory approvals, and evaluate the available evidence underpinning them, as a step towards identifying best practice and areas for improvement. 36 AIaMDs from 28 manufacturers were identified – 97% (35/36) approved in the EU, 22% (8/36) in Australia, an…

The increasing role of AI in health care

There is growing recognition of the role AI can play in healthcare. Still, challenges remain around safety and regulation.

Various commercial AI models for the analysis of medical image data can be influenced by written comments on the images.

FDA Plans to Integrate Artificial Intelligence for Medical Device Oversight and Data Analysis

The U.S. Food and Drug Administration (FDA) has announc […] The post FDA Plans to Integrate Artificial Intelligence for Medical Device Oversight and Data Analysis first appeared on GeneOnline News. The post FDA Plans to Integrate Artificial Intelligence for Medical Device Oversight and Data Analysis appeared first on GeneOnline News.

Scaling gen AI in the medtech industry – RamaOnHealthcare

Medtech leaders can fully unleash gen AI by selecting key domains and workflows for transformation and aligning business and technology teams to develop