When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

In digital healthcare, AI drives innovations and improves patient outcomes by making processes more efficient.

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

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

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

“The FDA has made a commitment to advancing health equity as part of the CDRH 2022-2025 Strategic Priorities, including ...

Engaged BSI Group to start the process of obtaining regulatory clearance of the MODD1, next-generation insulin pump for the European market- Targeting Q1 2026 for expected clearance of the MODD1 in th ...

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

India’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO) has put an end to the vexed issue of the import of refurbished medical devices by clarifying that the current rules do ...

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 ...