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 ...
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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 ...
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 ...
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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.
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 ...
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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 ...
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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.
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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 ...
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BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations
BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA 510(k) clearance for its first artificial intelligence software, designed to ...