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 ...
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 ...
MedTech Dive6d
FDA cuts outlined in draft HHS budget
The cuts to the FDA are just one piece of the budget proposal, which looks to slash the HHS’ discretionary spending by ...
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 ...
Sedana Medical AB: Sedana Medical Receives FDA Approval for Early Access Program in the U.S.
Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sed ...
Business Weekly1d
Key FDA approval for Mursla Bio liver cancer solution
Mursla Bio, a Cambridge UK and Boston US leader in Extracellular Vesicle (EV) science, has received FDA approval for its lead ...
The Manila Times2d
Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy
Breakthrough Device Designation ("BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses ...
Medical Marketing & Media1d
With Dr. Marty Makary in power, the FDA’s future comes slightly more into view
Following massive layoffs and cuts at the FDA, Makary’s plan for the agency is yet to fully unfold. But he has hinted at what ...