Hosted on MSN1d
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 ...
Medscape1d
Science Behind FDA-Approved Genetic Test for OUD Questioned
A new study suggests clinical utility of the first FDA-approved genetic test to help gauge an individual’s risk for opioid ...
JD Supra1d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
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 ...
PharmiWeb10d
De Novo Request Helps Bring Low and Medium Risk Devices to Market
De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low ...
SiliconRepublic10d
CergenX making Waves with new FDA designation
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
조선일보9d
Koh Young Technology gains FDA approval for medical robot in brain surgery
Koh Young Technology gains FDA approval for medical robot in brain surgery Koh Young Technology secures FDA clearance for innovative robotic system in neurosurgery ...
MassDevice10d
CergenX wins FDA breakthrough nod for neonatal brain monitoring tech
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain ...
medtechdive8d
Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
Med Device Online2d
Enhancing Trust, Safety, And Performance Through Explainability In AI-Enabled Medical Devices
Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making ...