Compremium AG

Compremium's Non-Invasive CVP Device Receives FDA Breakthrough Designation

- Compremium AG received FDA Breakthrough Device Designation for its Quantis CVP system, a non-invasive technology designed to directly measure central venous pressure without catheterization. - The device also joined the FDA's Total Product Life Cycle Advisory Program (TAP), which provides coordinated regulatory engagement and accelerated development pathways. - Early clinical studies demonstrated promising correlation between non-invasive measurements and invasive catheter readings across clinically relevant pressure ranges with rapid, reproducible results. - The technology addresses critical unmet needs in hemodynamic monitoring for patients with sepsis, shock, heart failure, and fluid imbalances while reducing infection and thrombosis risks.