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  • Writer's pictureRyan Kelly

FDA Approve INSPIRE by Barnard Health : Landmark Decision

Updated: Jun 27, 2020

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:

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