Compremium AG has been recognized by the U.S. Food and Drug Administration (FDA) as a Breakthrough Device for its new technology that measures central venous pressure (CVP) without invasive procedures.
The device is also now part of the FDA’s Total Product Life Cycle (TAP) program, which supports smoother development and regulatory guidance.
Monitoring blood volume is essential for patients with conditions such as sepsis, heart failure, shock, or fluid imbalances.
Conventional methods rely on catheters, which can pose risks like infection and blood clots.
The Compremium Quantis CVP provides a safe, non-invasive solution suitable for both adults and children.
Early studies suggest it delivers fast and accurate readings comparable to traditional catheter measurements and is easy for healthcare providers to operate with minimal training.
By participating in the Breakthrough Devices and TAP programs, Compremium gains early FDA feedback and opportunities to collaborate with clinicians and insurers, helping speed the device’s development and adoption.
Quantis CVP expands on Compremium’s existing platform, which already holds FDA clearance and CE marking for other medical applications.
