The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...

This is just a sampling of medical advancements in 2024 chosen for their common presence in the American population. It is ...

The FDA recently issued draft guidances ... finding applications across medical devices and pharmaceutical development. In medical devices, AI models power tools such as software that analyzes ...

NeurAxis offers FDA-cleared IB-Stim device for pediatric IBS pain. Despite positive advancements, market recognition lags.

This piece is part of a series that dives deeper into the most prevalent themes of this year’s iteration of our flagship research piece, Charting Disruption. Click to read.

AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...

Development and Documentation "The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...

But the nature of the development process typical for such devices suggests many ... resulting in an FDA Class II recall as well as an ICS Medical Advisory from CISA.” That 2023 RCE ...

Biodegradable materials, including polymers, degrade naturally, reducing pollution and offering eco-friendly solutions for packaging and medical applications.