An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...
A new study suggests clinical utility of the first FDA-approved genetic test to help gauge an individual’s risk for opioid misuse prior to prescribing.
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain ...
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
Koh Young Technology gains FDA approval for medical robot in brain surgery Koh Young Technology secures FDA clearance for innovative robotic system in neurosurgery ...
Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making ...
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...