News

FDA rushed out agency-wide AI tool—it’s not going well
FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...
FDA's Embrace of AI to Speed Up Drug Approvals Leaves Industry Observers Excited, Uneasy
There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...
Scientists argue for more FDA oversight of health care AI tools
An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to ...
BioPharma Dive2d
FDA’s AI tool ‘Elsa’ is here, and the industry has questions
The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...
AI isn't replacing radiologists. Instead, they're using it to tackle time-sucking administrative tasks.
While clinical applications exist, radiologists are using AI to increase productivity, and to help them communicate ...
InvestorsHub on MSN10d
Hyperfine Gains FDA Clearance for Next-Gen Optive AI Imaging Software
Hyperfine, Inc. (NASDAQ: HYPR), the company behind the world’s first FDA-cleared portable MRI system powered by artificial ...
Investing News Network2d
HeartSciences Receives FDA Breakthrough Device Designation for MyoVista Insights AI-ECG Algorithm for Detecting Aortic Stenosis
Aortic Stenosis is a Serious and Widespread Condition; The AI-ECG Algorithm Offers a Powerful Diagnostic Solution Designed ...
Health Affairs8d
Podcast: FDA Vague Efforts to Scale Generative AI Internally By End of June
Health Affairs' Jeff Byers welcomes Senior Editor Michael Gerber back to the program to discuss the Food and Drug ...
FDA approves AI technology to help improve breast cancer detection
A breakthrough in AI breast cancer detection technology has been approved by the FDA. The tech company, “Clarity,” is responsible for the first FDA-approved AI platform that helps predict a woman’s ...
Cardiosense Launches Nationwide SEISMIC-HF II Study to Validate Its AI Algorithm for Non-Invasive Heart Failure Management
Cardiosense, a medical AI company transforming cardiovascular disease management, today announced the launch of SEISMIC-HF II, a nationwide study to validate the company’s machine learning algorithm ...