Note: This story was updated Aug. 25, 2020, to clarify that, according to NuvoAir, the regulatory entity in question is the European Medical Device Directive.
The NuvoAir Home platform, NuvoAir’s respiratory support system for patients with lung diseases such as cystic fibrosis (CF) and idiopathic pulmonary fibrosis (IPF), has been classified as a Class Im Medical Device according to the requirements of the European Medical Device Directive.
This classification means the device meets the safety and performance requirements for medical devices sold within the European Economic Area.
Devices falling in the Class I category are those that have a low-to-moderate risk of having a negative impact on human health. Within this class, devices that are named Im are those meant to be used to measure certain parameters.
“This clearance is an important stepping stone in our journey to become the respiratory platform of choice for patients and physicians,” Lorenzo Consoli, CEO of NuvoAir, said in a press release.
“By having the full platform cleared, NuvoAir can now expand its offering considerably to include other clinically relevant digital biomarkers, increasing our ability to understand when patients’ respiratory health is deteriorating,” Consoli said.
Survey findings showed that NuvoAir’s respiratory platform reduced the number of scheduled and urgent in-person consultations by more than 30% in CF patients who had been using the system regularly to monitor their lung function at home for at least six months.
This may enable both patients and healthcare services to save money that otherwise would be spent on in-person appointments, and at the same time lower patients’ risk of contracting COVID-19.
NuvoAir’s respiratory monitoring system also incorporates analytical analyses that help physicians caring for patients with lung diseases to make more informed decisions regarding their patients’ follow-up and healthcare plan, as it removes subjectivity from their personal assessments of their own health status.
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