eWeek3d
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 ...
MassDevice9d
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 ...
STAT9d
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.
JD Supra16h
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American ...
STAT1d
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.
MassDevice2d
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.
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 ...
JD Supra7d
Upcoming FDA Meeting Focuses on Generative AI in Medical Devices
The U.S. Food and Drug Administration will focus on “Total Product Lifecycle Considerations for Generative AI-Enabled Devices” during its ...
Fierce Healthcare8d
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 ...
FierceBiotech13d
FDA clears Omron blood pressure cuff with afib pulse wave detection
The FDA has granted a de novo clearance to a wearable device—with a form factor you’re familiar with—that can check patients ...
BrightHeart receives 510(k) clearance from FDA for prenatal ultrasound software
The software is designed to improve the accuracy of detecting morphological abnormalities during foetal heart ultrasound ...
Asia One2d
Neurophet Secures FDA 510(k) Clearance for Multiple Sclerosis Analysis with 'Neurophet AQUA'
New features include advanced analysis of multiple sclerosis (MS) and white matter hyperintensities alongside brain atrophy ...