August 4, 2025
Oslo, Norway – 4 Aug 2025 – RESPINOR, a MedTech company at the forefront of non-invasive diaphragm monitoring, today announces it has received the European Community (EC) Certificate from notified body TÜV SÜD, granting CE mark for the class IIa medical device, RESPINOR DXT®, under the EU Medical Device Regulation (MDR 2017/745).
In the ICU, every breath matters. Every decision, especially the decision to extubate a patient from mechanical ventilation, can change a life, a recovery path, and a family’s future.
This regulatory milestone enables RESPINOR as of today to market RESPINOR DXT across the European Economic Area (EEA) - an important commercial inflection point for the company. The CE mark confirms compliance with EU regulations for safety, clinical performance, and quality.
A Paradigm Shift in ICU Respiratory Care
With two small, ultrasound-based sensors, DXT delivers non-invasive, easy-to-use monitoring of diaphragm movement - providing clear, actionable insight with minimal training required. This empowers every ICU clinician to detect diaphragm dysfunction and intervene in time, giving patients a better chance of breathing safely on their own.
Clinical and Commercial Impact
Clinical studies underscore the urgency: patients with diaphragm excursion below 1.1 cm are 8 times more likely to experience acute respiratory failure after extubation. RESPINOR DXT makes this insight accessible, trackable, and actionable - right at the bedside, when it matters most.
“Achieving CE mark under the EU MDR is a defining milestone for RESPINOR and a critical step towards realizing our mission,” said Trude Tingvoll, CEO of RESPINOR. “We are here to change respiratory health by providing an objective measure of diaphragm function - empowering faster decisions in critical care, for better patient outcomes and lower healthcare costs. With CE certification now in place, we’re finally ready to meet this huge unmet medical need and bring RESPINOR DXT to ICUs across Europe, delivering value to clinicians, patients, and healthcare systems alike.”
The CE Mark follows successful clinical evaluations across multiple European centers and reflects RESPINOR’s commitment to quality, innovation, and patient-centered care.
“RESPINOR DXT represents a meaningful advancement in critical care by providing real-time, continuous insights into diaphragm function with a non-invasive, operator-independent technology,” said Prof. Alexandre Demoule, Head of Medical Intensive Care Unit and Weaning Centre – Respiratory Division La Pitié-Salpêtrière Hospital, Paris, France. “By identifying patients at risk of extubation failure, it supports more informed clinical decisions during the weaning process. This can help reduce emergency re-intubations and personalizing care. The ultimate goal would be to shorten ICU and hospital stays.”
Unlocking Growth Across the EEA
The global mechanical ventilation market is forecasted to reach $6.1 billion by 2028, with increasing focus on reducing ICU stays, ventilator-associated complications, and hospital readmissions.
With the CE mark obtained, RESPINOR is now positioned to:
About RESPINOR:
RESPINOR is a MedTech company based in Oslo, Norway, focused on advancing critical care through non-invasive diaphragm monitoring. Its flagship product, RESPINOR DXT, is designed to support clinicians in optimizing ventilator support and improving outcomes in critical care settings. For more information, visit www.respinor.com.
Contact information:
Trude Tingvoll, CEO
Email: t.tingvoll@respinor.com
Phone: +47 474 53 313
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RESPINOR: MedTech innovator specializing in diaphragm monitoring, introducing DXT, a non-invasive ultrasound-based technology to improve critical care and outcomes.