Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
Bill would require anti-choking devices in Ga. day cares, but are they safe?
Dr. Ben Spitalnick says that while well-intentioned, an anti-choking device requirement might do more harm than good for ...
MedTech Dive1d
Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
US FDA says shortage of dialysis device component to extend through early fall
The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in ...
MPR1d
Considerable Proportion of Medical Device Adverse Events Reported Late
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 ...
JD Supra1d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
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 ...
FDA warns of scramble for work and parking space in Monday return to office
The U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles ...
MassDevice2d
Lifeward wins FDA nod for next-gen exoskeleton
Lifeward announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk ...
MassDevice2d
FDA says Intuitive da Vinci 5 foot pedal recall is Class II
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...
STAT2d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
Trump’s FDA and NIH picks clear committee, teeing up final Senate confirmation
The Senate Health, Education, Labor, and Pensions Committee approved Dr. Jayanta Bhattacharya’s nomination to be NIH director ...
STAT2d
Trump’s picks to run FDA and NIH win approval from Senate’s health committee
Jay Bhattacharya, nominee for National Institutes of Health director, and FDA pick Marty Makary clear key Senate committee.