Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
Dr. Ben Spitalnick says that while well-intentioned, an anti-choking device requirement might do more harm than good for ...
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in ...
HealthDay News — Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion are submitted late, according to a study published online March 12 ...
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles ...
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
The Senate Health, Education, Labor, and Pensions Committee approved Dr. Jayanta Bhattacharya’s nomination to be NIH director ...
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.