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FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal [...]

FDA now requires a cyber security plan in your medical device submission. On June 14, 2013, FDA issued Draft Guidance on Content of Premarket Submissions for Management of Cybersecurity in [...]

Telemedicine laws will change if the U.S. Congress enacts the “Healthcare Innovation and Marketplace Technologies Act” (“HIMTA”), a bill which seeks to establish the “Office of Mobile Health” [...]

Medical researchers are growing spare parts from stem cells inside the human body.Another practice, called bioprinting, builds body parts much like an inkjet printer: