Kitea Selected: FDA Total Product Life Cycle Advisory Program (TAP)

Kitea Health are thrilled to announce that Kitea has reached another significant milestone in our mission to enhance the lives of individuals with hydrocephalus. Off the back of the FDA Breakthrough Device Designation, we are proud to join the FDA’s exclusive Total Product Life Cycle Advisory (TAP) program.

As one of only 65 devices worldwide selected for this program, we will benefit from expedited interactions with the FDA, akin to a breakthrough designation on steroids! This program also facilitates crucial engagements with payers and patient groups, underscoring the FDA’s commitment to ensuring innovative products are not only approved but also reimbursed promptly.

Following our initial meeting, we are highly encouraged by the agency’s interest in our product and are eager to advance our efforts to align with Centers for Medicare and Medicaid Services (CMS) and insurance companies in the US.