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Examples of SaMD include software that makes a diagnosis using patient information, X-ray image processing software and smart phone apps that calculate a patient’s required insulin doses using their blood glucose levels. Read More
Final guidance issued by the FDA on Friday outlines what devicemakers should know about manufacturing site changes and when they should submit supplements. Read More
FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019. Read More
The FDA issued final guidance on user fees and refunds for device biologics license and premarket approval applications with just minor changes from the October 2017 draft. Read More
FDA Commissioner Scott Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer. Read More
Ev3 agreed to plead guilty to misdemeanor charges that it encouraged unproven and potentially dangerous uses of its Onyx Liquid Embolic System. Read More