FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
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 ...
Medical Device Network on MSN7d
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Nature11d
Drug regulation articles from across Nature Portfolio
We analysed new anticancer drug indications approved by the FDA and EMA between 2020 and 2023 using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale quality-of-life ...
Roll Call14d
Makary tells Senate panel he plans to review FDA job cuts
President Donald Trump’s pick to lead the Food and Drug Administration vowed Thursday to review the Trump administration’s sweeping job cuts at the agency. “I have not been involved in any ...
BioSpace14d
MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson’s Disease
Rx-only medical device with the U.S. Food and Drug Administration (FDA). The company unveiled the system’s brand name: Movive ™. “Movive leverages the well-researched power of rhythmic auditory ...
Business Times15d
Singapore to get new regulations to tackle online sale of non-compliant mobility devices
REGULATIONS against online marketplace platforms and retailers selling non-compliant active mobility devices will be introduced here, said Senior Parliamentary Secretary for Transport Baey Yam Keng on ...
The Australian16d
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor is executing a modular review process with the FDA, whereby modules covering ... CE mark certification under new European Medical Device Regulation. IMR is working to improve cardiac ...
NHS England17d
Medical devices and digital tools
These are categorised differently into 4 main groups. Detailed information aimed at suppliers on how to classify medical device and what regulations are required can be found at the following links: ...
HuffPost23d
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
with a particular emphasis on the more than 220 people in the FDA’s Center for Devices and Radiological Health. Staffers at the unit are responsible for reviewing and approving medical devices like ...
Yahoo23d
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
34,796 people played the daily Crossword recently. Can you solve it faster than others?34,796 people played the daily Crossword recently. Can you solve it faster than others?
Business Standard23d
FDA to rehire probationary medical device staffers fired only days earlier
Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been rescinded effective immediately, ...