Nima AKHLAGHI

 

Dr. Akhlaghi is an associate director for Digital Health and Imaging Regulatory Affairs at MCRA. He is a former FDA medical device lead reviewer with deep understanding in regulatory requirements and processes for medical device and Digital health fields. He specializes in Medical Imaging, Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), AI/ML-Enabled Medical Devices including Quantitative Imaging and Computer Aided Devices (CADe, CADx, CADe/x, CADt,). Dr. Akhlaghi received his Ph.D. in Electrical and Computer Engineering specializing in Biomedical Imaging from George Mason University in Virginia.