Fierce Healthcare December 11, 2023
Floreo, maker of virtaul reality (VR) behavioral therapy content, has received the Food and Drug Administration’s breakthrough device designation.
The company has also been accepted into the newer Total Product Life Cycle Advisory Program (TAP). While the breakthrough device designation helps streamline the process for medical device premarket approval, the TAP Program offers insights and resources to assist with the path to commercialization.
“Floreo is seeking full market authorization and a label to further recognize its effectiveness in augmenting therapy and outcomes,” Vijay Ravindran, co-founder and CEO of Floreo, told Fierce Healthcare. The other goal with full market authorization is “opening up any and all reimbursement pathways so that Floreo can reach the million-plus families searching for better...
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