By Anastassia Gliadkovskaya - Dec 11, 2023 4:00pm -
Floreo, maker of virtual 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 outcomes,” he added.
The TAP program, established at the start of 2023, provides opportunities for dialogues with industry stakeholders, like payers and providers, through the product life cycle. The goal is to guide the device to success by facilitating discussions between companies and payers on the necessary evidence for reimbursement in terms of volume and quality. A breakthrough device designation is required to apply for the TAP program.
The breakthrough label fast-tracks new technologies aimed at treating life-threatening or irreversible conditions by giving tech makers a direct communication channel with the FDA and moving subsequent regulatory submissions to the top of the review pile. To qualify for the Breakthrough Device Program, companies must demonstrate credible evidence that their technology addresses unmet needs and offers potential improvements over current standard treatments.
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