Regulatory tips from a breakthrough noninvasive device startup

Compremium's Quantis CVP, a noninvasive central venous pressure measurement device, received FDA Breakthrough Device designation in January 2026 and was enrolled in the FDA's Total Product Life Cycle Advisory Program (TAP). The program provides regulatory guidance to accelerate development of high-priority medical devices. The designation and TAP enrollment support expedited patient access pathways for the device.