Menlo Park, CA — Adaptyx Biosciences, a Stanford University spinoff developing a wearable biosensing platform capable of measuring multiple biomarkers continuously and simultaneously, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its continuous cortisol monitoring device, and that the company has been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP).
Adaptyx’s continuous cortisol monitoring device is designed to support diagnosis and management of suspected and active excess cortisol states and low cortisol states. Excess cortisol, known as hypercortisolism, can result from Cushing syndrome and other conditions, while low cortisol or hypocortisolism can be caused by adrenal insufficiency. Breakthrough Device Designation gives Adaptyx expedited FDA review and more frequent, structured interaction with the agency as the continuous cortisol monitor moves through development. Adaptyx's engagement in TAP pairs the company with dedicated FDA review teams for proactive, structured feedback and early access to payers and provider organizations to align regulatory and reimbursement strategy in parallel.