FDA Approve INSPIRE by Barnard Health : Landmark Decision
Updated: Jun 27
Principal Investigator Katharine Barnard-Kelly received notice from the US Food and Drugs Agency confirming the award of MDDT qualification of the novel INSPIRE psychosocial measures. This landmark decision, the first ever diabetes-related Medical Device Development Tool, demonstrates the importance the FDA place on psychosocial outcomes alongisde biomedical outcomes, as well as the very high standards of scientific rigour Prof Barnard-Kelly and her team executed throughout the project.
The FDA announcement:
Also, coverage from Close Concerns: