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. The FDA clearance paves the way for use of Sensometrics® Software in a clinical context, and allows cooperation with industrial players in the US market.
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. “So we are very satisfied to have received our clearance, and see it as a seal of quality having both CE certification and FDA clearance for the company. "
The Food and Drug Administration (FDA) is responsible for public health in the United States, through the regulation of all food, medicines and products for use in health care, including Sensometrics® Software. FDA regulates about 25% of the all personal consumption in the US.
dPCom A/S is a Norwegian medical technology company, which allows healthcare professionals to safely and accurately monitor pressures in patients. The company has developed a new innovative technology that significantly improves the diagnostic information from invasive and non-invasive pressure measurements, focusing on intracranial pressure (ICP) and blood pressure (ABP). The new method is suitable for use in intensive care units (ICU) for the monitoring of brain disease/injury, and for diagnostic pressure monitoring in general. Sensometrics® Technology significantly improves pressure diagnostics for healthcare professionals and has a leading role in non-invasive intracranial pressure diagnostics.
dPCom A/S was founded in 2001 after physicians at The National Hospital (Rikshospitalet) in Oslo discovered problems with traditional pressure monitoring methodology. A series of clinical studies have since been carried out , and numerous scientific articles documenting the weaknesses of traditional measuring methods have been published.
Sensometrics® Software is compatible with several industrial pressure measuring devices, and is CE certified and has received US clearance from the FDA. The technology is protected by several patents.
Sensometrics® and Always safe pressure diagnostics™ are registered trademarks.
Sensometrics® Technology provides safe diagnostic information from intracranial and blood pressure monitoring. The technology is of particular significance for the management of patients with hydrocephalus, head injury, stroke, dementia, chronic headache, brain tumors, and diseases caused by arterial hypertension. Sensometrics® Technology identifies the cardiac-induced pressure waves from various locations, including non-invasive surface locations, and is the leading technology today for dynamic invasive and non-invasive pressure monitoring.