The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...

Kneat's SaaS model automates validation processes in pharma and biotech, reducing errors and ensuring compliance. Learn why ...

The company expects next quarter to read out initial data from its Heart-2 trial, which is testing a one-time treatment for people with genetically elevated cholesterol.

Primary investigator and presenter of the study, Ahmed H. Zedan, MD, PhD from Lillebaelt Hospital - University Hospital of Southern Denmark said: ”Proclarix can be safely used to reduce performed ...

While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...