NTA Helitron V CO2 – [H2]
Ready for IVDR Certification:
Excellence, Innovation and Outstanding Results!
Following the success of the clinical trials, realized and supervised by Prof. Berardino Vaira – Full Professor of Internal Medicine and Specialist in Gastroenterology and Digestive Endoscopy at Alma Mater Studiorum University of Bologna – and his team, our portable diagnostic system is nearing official certification, confirming its role as a revolutionary development in the medical sector.
A Milestone That Changes the Future of Diagnostics
With great pride, we announce that our cutting-edge device, Helitron V CO2 – [H2], is about to successfully complete the IVDR certification process. This significant milestone attests to the compliance of our device with the highest quality and safety standards required in the medical sector.
Helitron V CO2 – [H2] represents a new frontier in portable diagnostics, thanks to its ability to perform fast, accurate tests without the need for complex systems such as CO₂ and He cylinders or chromatographic columns.
Exceptional Performance in Clinical Trials
The validation of the device has been confirmed by the results obtained during clinical trials, where our device demonstrated outstanding performance:
- Accuracy: 98.51%
- Sensitivity: 96.84%
- Specificity: 99.16%
These figures highlight the system’s ability to deliver fast, precise, and reliable results, which are essential for the early diagnosis of critical conditions such as Helicobacter pylori infection, a risk factor for gastric cancer.
A Look to the Future
The journey towards IVDR certification is not just a goal but also a starting point. With this certification, Helitron V CO2 – [H2] will be ready for the global market, bringing with it the promise of more accessible, efficient, and proactive diagnostics.
Stay Connected
We are just a step away from the official IVDR certification, and we can’t wait to share it with you. Get ready to discover a new standard of excellence in medical diagnostics.
STAY TUNED Learn more about Helitron V CO2 – [H2] and our revolutionary technology!
