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 ...
PixCell Medical's HemoScreen CBC Analyzer Achieves IVDR Certification--A Game-Changer for Point-of-Care Diagnostics
PixCell Medical, a leading innovator in point-of-care diagnostics, proudly announces that its groundbreaking HemoScreen CBC ...
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.
Medindia2d
LifeSignals Receives FDA 510(k) Approval for UbiqVue™ 2A Multiparameter System
UbiqVue 2A Multiparameter System has received FDA Class II 510(k) clearance, marking a significant milestone in continuous wireless patient monitoring for population health management. UbiqVue 2A ...
wahanariau2d
Philips and Icometrix Advance Precision Diagnosis in Neurology with Innovative AI-based Imaging Solutions at #RSNA24
November 25, 2024icometrix’ FDA-cleared quantitative brain solution for neurological conditions including Alzheimer’s and ...
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.
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 ...
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 ...
BioWorld5d
Ultromics’ AI software for cardiac amyloidosis gets FDA approval
Ultromics Ltd. received clearance from the U.S. FDA for Echogo Amyloidosis, its artificial intelligence-enhanced software ...
Le Lézard5d
Redefining the Standard of Care: Introducing the Aulisa® Monitor Camera for Advanced Patient Monitoring
incorporating Artificial Intelligence (AI) technologies that can detect adverse events and potentially save lives. Aulisa® Medical USA, Inc., a leader in FDA-cleared, wearable, wireless continuous ...
MassDevice5d
Philips picks up FDA nod for remote imaging capabilities
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for a number of remote imaging features.