JD Supra2h
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
stockhead on MSN3d
Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.
TipRanks on MSN10d
Merit Medical Celebrates FDA Approval of WRAPSODY™
An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
JD Supra11h
State Licensing Requirements: Are You Prepared?
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...
GlobalData on MSN2d
Femasys gains approvals for infertility and diagnostic products in Israel
Failed to fetch dynamically imported module: https://finance.yahoo.com/assets/_app/immutable/nodes/105.JzBkOQ-g.js ...
Los Angeles Business Journal12d
Avita Gets FDA Nod For Device
Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...
TheCable12h
NAFDAC, African regulatory agencies sign MoU to speed up medicine approval
African National regulatory agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a ...
Stockhead on MSN8d
Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
The trial’s lead investigator, professor Daniel Claassen from Vanderbilt University Medical Centre ... EBR), which is ...
News Medical on MSN6d
Key information to consider before getting breast implants
Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery?
GlobalData on MSN11d
Caranx Medical submits AI TAVI-TAVR guide software to FDA
Caranx Medical has submitted TAVIPILOT Soft, an AI-based guide software for use during Transcatheter Aortic Valve ...
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...