eWeek6d
FDA Clears BrightHeart’s AI Ultrasound Software for Fetal Heart Monitoring — What This Means for Expecting Parents
BrightHeart's revolutionary AI ultrasound software has received FDA clearance, transforming fetal heart monitoring for ...
MassDevice12d
BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech
BrightHeart announced that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of ...
STAT11d
In first meeting of FDA’s digital health advisory committee, generative AI is up for debate
The FDA's digital health advisory committee is expected to weigh in on how generative AI should be regulated by the agency.
STAT4d
Why AI may not help decrease radiologists’ burnout
New study finds that AI didn't help reduce radiologists' burnout, HHS called out for not auditing HIPAA compliance, and more.
Fierce Healthcare11d
FDA advisory committee to roll up sleeves on generative AI this week
The Food and Drug Administration will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the ...
Ultromics obtains Breakthrough Device FDA clearance for its Cardiac Amyloidosis screening device through the Total Product Lifecycle Advisory Program
Ultromics' EchoGo® Amyloidosis, clinical AI for echocardiography with the potential to revolutionize early detection of ...
MassDevice5d
Philips, Icometrix unveil AI-powered brain imaging tech
Philips (NYSE:PHG) announced today that it teamed up with Icometrix to deploy an AI-driven brain scan solution.
JD Supra3d
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
The FDA has been evaluating AI-enabled medical devices for nearly 30 years with the FDA’s first approval of a partially AI-enabled device coming in 1995, when the FDA approved PAPNET ...
Medical Design and Outsourcing9d
Perimeter Medical Imaging AI announces pivotal study results for B-Series OCT with ImgAssist AI 2.0
Perimeter Medical Imaging AI sad it expects to file an FDA PMA application for its B-Series OCT system with ImgAssist AI 2.0 ...
KTLA10d
Ultromics obtains Breakthrough Device FDA clearance for its Cardiac Amyloidosis screening device through the Total Product Lifecycle Advisory Program
The device was among 15 breakthrough cardiovascular ... the University of Oxford (UK), has expanded its portfolio of FDA-cleared, AI-based Echo diagnostics to include EchoGo ® Amyloidosis.