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  • Ryan Kelly

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:


https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt


Also, coverage from Close Concerns:


https://www.closeconcerns.com/knowledgebase/r/fc3cb384?utm_source=Closer+Look+Subscribers+2018&utm_campaign=8feeae76f4-2020-06-25_Tandem_Sugarmate06_25_2020&utm_medium=email&utm_term=0_c55d924bf1-8feeae76f4-412246149





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