FDA classifies as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect infor...
Attorney Paulette Thomas says hospitals and other medical device vendors should pay attention to recent FDA guidelines on medical device cybersecurity...
A JAMA Special Communication says spending on medical marketing increased significantly between 1997 and 2016, but oversight of such marketing has rem...
CNN reports FDA employees saying they fear the government shutdown at their agency could cost lives, and commissioner Scott Gottlieb asks the network ...
The U.S. House of Representatives plans to vote this week to fund FDA under an Agriculture, Rural Development, Food and Drug Administration, and Relat...
Attorney Jeffrey Shapiro questions the need for an FDA push to get 510(k) submissions to rely on newer predicates.
FDA grants Awak Technologies a breakthrough designation for its Awak Peritoneal Dialysis device, a wearable and ultra-portable peritoneal dialysis sys...
FDA clears an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be as...