Machine Learning Based Software News Today

/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an...

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...

A systems engineering approach to equitable health care solutions

FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems. We will review FDA’s digital health improvement highlights and take a quick look at AI/ML-enabled medical devices.

In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s...

HPE GreenLake Scores AI-As-A-Service Pact With AI X-ray Imaging Pioneer Carestream ‘HPE is a known leader in as a service, but their solutions were also more vendor agnostic from an applications stack perspective,’ says Carestream Health CTO Dharmendu Damany. ‘Also HPE had solutions that supported seamless deployment and management of the devices at the micro-edge, edge, private cloud and public cloud, so the scale was there.’ By Steven Burke May 20, 20...

FDA publishes Action Plan to regulate AI and ML based products The FDA has advanced an Action Plan focussed on possible means and methods of regulating AI/ML based products (AP)Premium The Action Plan furthers and builds on concepts covered in a discussion paper released in April 2019 Share Via Read Full Story On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelli...

To embed, copy and paste the code into your website or blog: On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussio...

Today, the U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

/PRNewswire/ -- Today, the U.S. Food and Drug Administration released the agencys first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a...