GlobalData on MSN14h
Navi lands FDA clearance for vascular access placement system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Neonav electrocardiogram (ECG) tip location system, a central venous access device (CVAD) placement platform developed by ...
IEEE7d
Patch and Model Size Characterization for On-Device Efficient-ViTs on Small Datasets Using 12 Quantitative Metrics
and seven device-related (DR) quantitative metrics, 2) using which we thoroughly characterize the effects of ViT hyper-parameters on small datasets in terms of patch size and model size, and then 3) ...
Canada14d
Pre-market guidance for machine learning-enabled medical devices
to achieve their intended medical purpose are known as machine learning-enabled medical devices (MLMD). "Medical purpose" refers to parts (a) through (e) of the "device" definition within the Food and ...
WCVB Channel 5 Boston22d
Lifesaving medical devices being built in Bedford, Massachusetts
LIFE SAVING MEDICAL DEVICE SYSTEMS. THIS IS A CRITICAL CARE LINE. THIS IS WHERE WE MAKE OUR BLOOD GAS ANALYZERS. MARK OLSON IS THE CHIEF MANUFACTURING OFFICER FOR WARFARIN. THIS MASSACHUSETTS ...
Los Angeles Business Journal23d
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 harvesting device designed to treat small-scale wounds. Avita’s original ...
Press Enterprise24d
Is repurposing body parts a new status symbol?
In early November, Emily James, 27, of Kansas City, Missouri, underwent a most unusual and expensive ($17,000) body-altering surgery, the New York Post... Main Office 570-387-1234 ...
Healthcare Dive26d
Sara Brenner named acting FDA commissioner
Sara Brenner, a Food and Drug Administration official in the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made online to the regulator ...
Reuters26d
US FDA drops web pages on improving clinical trial diversity
The FDA's Diversity Action Plan draft guidance to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act. It aims to significantly increase participation of ...
BioPharma Dive26d
Sara Brenner, FDA device official, named agency’s acting head
Sara Brenner, a Food and Drug Administration official within the agency’s medical device division, has been named the FDA’s acting commissioner, according to an update made to a webpage listing ...
Gizmodo27d
Medical Device Company Suddenly Stops Hospitals From Fixing Machines Themselves
A medical device company that ... hampering repairs that could extend device lifespans. The company now offers official replacement parts and repair tools for some devices with plans to expand ...
MassDevice27d
FDA adds RevMedica stapling platform to STeP program
STeP, a collaborative program, helps reduce the time needed to develop and obtain marketing authorization for eligible devices. The FDA launched STeP in 2021, modeling the program on its ...