Compremium’s Non-Invasive Central Venous Pressure Measurement Wins FDA Breakthrough Nod

Compremium AG revealed that the U.S. Food and Drug Administration (FDA) awarded Breakthrough Device Designation to its solution that directly measures central venous pressure (CVP) non-invasively. The device also joined the FDA’s Total Product Life Cycle Advisory Program (TAP).

Volume assessment is needed for hemodynamic measurement of patients requiring close monitoring for acute conditions like sepsis, shock, heart failure, venous congestion, and fluid under- or overload. Today’s standard relies on CVP measured invasively with catheterization, which can include risks of infection and thrombosis.

Compremium Quantis CVP is a non-invasive solution to quantify volume at the bedside and is designed for both adult and pediatric patients. Early clinical studies showed promising correlation between non-invasive measurements and invasive catheter readings across clinically relevant pressure ranges. The measurements, according to the Swiss company, were rapid, reproducible, and achievable with limited operator training.

“Receiving Breakthrough Device Designation and joining the FDA’s Total Product Life Cycle Advisory Program reflects both the clinical importance of the unmet medical need we are addressing and the rigor of our development approach,” said Vincent Baumann, CEO of Compremium. “These programs allow us to de-risk the development and shorten the time to market for Quantis CVP while strengthening our path toward clinical adoption through early engagement with FDA experts, clinicians, and payers.”

Compremium Quantis CVP is built on the company’s established platform, parts of which are already FDA-cleared and CE marked for another clinical application.

In May 2025, the company appointed Kolaleh Eskandanian, Ph.D., as its chief strategy and innovation officer and head of its newly formed Division of Pediatrics and Special Populations.