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Clinical Trials
6
0 active
Approvals
0
Total approvals
Agencies
Regulatory bodies
Founded
N/A
Completed
3
50.0%
Recruiting
2
33.3%
Withdrawn
1
16.7%
No approval data available
- 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.