Compremium’s noninvasive CVP device wins FDA Breakthrough designation

Compremium AG said that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Quantis CVP system, a noninvasive technology designed to directly measure central venous pressure, a key indicator of a patient’s fluid status. The device has also been accepted into the FDA’s Total Product Life Cycle Advisory Program, known as TAP.

Central venous pressure is widely used to guide hemodynamic management in patients who require close monitoring, including those with sepsis, shock, heart failure, venous congestion and fluid imbalance. The current gold standard for measuring CVP relies on invasive catheterization, which carries risks such as infection, thrombosis and other complications.

Compremium said Quantis CVP is designed to provide a noninvasive alternative that can be used at the bedside in both adult and pediatric patients. In early clinical studies, the company reported a strong correlation between Quantis CVP measurements and readings obtained through invasive catheters across clinically relevant pressure ranges. The measurements were rapid, reproducible and could be performed with limited operator training, according to the company.

“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, chief executive officer 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.”

The FDA’s Breakthrough Devices Program is intended to speed the development and review of medical technologies that may offer more effective diagnosis or treatment of serious or life-threatening conditions. Devices accepted into the program can receive prioritized regulatory interactions and more frequent communication with the agency.

The TAP Program extends that engagement across the full product life cycle, offering coordinated input on regulatory strategy and facilitating discussions with clinicians and payers to support eventual adoption and reimbursement.

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

Advances accelerate shift toward noninvasive hemodynamic monitoring

Compremium’s announcement comes amid broader advances in noninvasive hemodynamic monitoring, a sector that has drawn increasing attention as hospitals seek safer, faster and more cost-effective ways to manage critically ill patients.

In recent years, device developers have made progress in using ultrasound, wearable sensors and advanced signal-processing algorithms to estimate cardiovascular parameters that previously required invasive lines. Noninvasive cardiac output monitoring, for example, has expanded beyond operating rooms into emergency departments and intensive care units, supported by improvements in sensor accuracy and software analytics.

Artificial intelligence and machine learning are also playing a growing role, enabling devices to combine multiple physiologic signals—such as blood pressure waveforms, respiratory patterns and peripheral perfusion—into more reliable assessments of a patient’s volume status. These tools are increasingly designed to integrate with electronic health records, allowing clinicians to track trends over time rather than rely on isolated measurements.

The push toward noninvasive solutions has been further fueled by staffing shortages and infection-control concerns. Technologies that require less specialized training and reduce the need for central lines can help lower complication rates and free up clinical resources, particularly in high-acuity settings.

Regulators have also signaled support for innovation in this area. Programs such as the FDA’s Breakthrough Devices pathway and TAP are intended to bring promising technologies to patients sooner while maintaining rigorous safety and effectiveness standards.

As these technologies mature, clinicians and health systems are evaluating how noninvasive monitoring can complement or, in some cases, replace invasive methods. While invasive measurements remain essential in certain situations, recent advancements suggest that noninvasive tools are poised to play a larger role in routine hemodynamic management, especially for early assessment and ongoing monitoring.