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 ...
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.
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.
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.
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 ...
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 ...
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 ...
Neurotech Innovator UNEEG Medical Receives FDA Breakthrough Device Designation Within Monitoring and Diagnostic of Epilepsy
FDA Breakthrough Device Designation is granted to UNEEG's Subcutaneous EEG Implant System and will expedite the review of ...
KTLA7d
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.