News

CGBIO Receives FDA IDE Approval for NOVOSIS PUTTY, Advancing Toward U.S. Market Entry
CGBIO(CEO Hyun Seung Yu), a leading Korean company specializing in bio-regenerative medicine, proudly announces that its ...
Orchestra BioMed Shares Rally After FDA Breakthrough Approval for Blood-Pressure Device
Orchestra BioMed Holdings shares rallied premarket after the maker of medical devices said a blood-pressure mechanism received breakthrough status from the U.S. Food and Drug Administration, allowing ...
News-Medical.Net on MSN1d
Mursla Bio receives FDA breakthrough device designation for EvoLiver test
Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...
FDA warning hits Minnesota-made infusion pumps for missing regulatory checks
Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...
Star Tribune16d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...
Medical Xpress16d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
Get Instant Summarized Text (Gist) The FDA's approval of high-risk medical devices has reached a 10-year low, attributed to significant workforce reductions. Despite an increase in pending ...
When AI In Medical Devices Evolves Faster Than Regulations: How Do We Keep Up?
The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.
FDA: Job cuts at US health agency raises concerns over drug approvals
The US FDA is coping with a series of Trump-imposed job cuts. These are starting to hamper food safety and pharmaceutical ...
Stockhead on MSN11d
Health Check: With the FDA’s approval, EBR is ready to revolutionise the heart failure device market
The US FDA has approved EBR System's leadless pacemaker WISE, the only heart device able to deliver left-ventricle ...
Stockhead on MSN1d
Dr Boreham’s Crucible: WISE guys de-risked with FDA approval for EBR cardiac device
Tim Boreham sharpens his knifes to look under the hood at cardiac pacing device innovator EBR Systems after its US FDA ...
FDA Grants Authorisation for Minder®, the First and Only Implantable Continuous EEG Monitor Approved in US
Epiminder, a pioneering medical device and information solutions company, today announced that it has been granted FDA authorisation via the De Novo classification for Minder, its proprietary ...