dPCom received FDA clearance in November 2010 for its software, Sensometrics® Software. Sensometrics® Software meets the strict requirements for products applied in the health sector in the United States. dPCom is in a unique position after receiving FDA clearance, CE certification, 10 approved patents and proof of concept through many clinical studies.
Sensometrics® Software was already CE certified for Europe. "But although CE certification in many ways is the European counterpart of FDA in the United States, it is not always the case that having one means the other will follow,” says Stadheim. “Many companies may experience that FDA clearance can be a difficult process, especially when new technologies are introduced. This can be a major challenge because the major commercial possibilities often start in the US,” says Stadheim.
The FDA clearance and CE certification allows Sensometrics® Software to be used in a clinical context in both Europe and the US and allows cooperation with industrial players in the European and the US market.
The technology behind Sensometrics® Technology is protected by 10 approved patents in the United States, Europe and Asia (and other patents pending). The patents are based on an innovative method for processing pressure signals from the body. Sensometrics® Technology is crucial for the management of patients with hydrocephalus, dementia and migraine, as well as patients in need of intensive care surveillance (ICU), such as patients with stroke or brain injury, wherein intracranial pressure (ICP) may be increased.
“Our method is unique, protected, and the only method that provides safe measurement of pressures based on the recognition of cardiac-induced single pressure waves,” concludes Stadheim.
10 years of research supports Norwegian Sensometrics Technology.
The potential of Sensometrics Technology is supported by 10 years of research. More than 30 scientific publications and clinical studies of various groups of patients, in different clinical settings, reveal that there is considerable potential for improvement in the measurement of blood pressure (ABP) and intracranial pressure (ICP). This potential for improvement affects the diagnostic information, treatment and management of large groups of patients.
Sensometrics® Technology addresses these challenges and improves intracranial pressure (ICP) measurement and blood pressure (ABP) measurement and has proven to be particularly useful for patients with stroke, hydrocephalus and other neurological conditions with abnormal intracranial pressure (ICP).
A crucial observation from clinical studies is that Sensometrics® may discover abnormal pressures in situations where traditional methodology reveals normal pressure. This can occur in as many as 50 % of patients who are in need of intracranial pressure (ICP) measurement. Sensometrics® Technology helps physicians obtain better diagnosis, uncovering disease and ensuring that patients receive the necessary treatment.
See
www.dPCom.no for more information and a complete list of scientific publications.
