ARQonFeb 10, 20211 minUS FDA Action Plan on Artificial Intelligence/Machine Learning-Based Software as a Medical Device·U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a...
ARQonFeb 10, 20213 minUS FDA announced COVID-19 related devices including surgical glovesThe US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification...
ARQonFeb 8, 20211 minASEANMed Nations Make Device Progress Despite Pandemic: Asian Regulatory DiscussionExecutive summary Medtech industry representatives from Thailand, Myanmar, Indonesia, Singapore and the Philippines gave updates on...
ARQonFeb 5, 20211 minMalaysia: Transition Period for Medical Device AdvertisementThe Medical Device Authority (MDA) of Malaysia published a new circular letter regarding a transition period for companies to comply with...