In a major milestone for Oulu-based NE Device SW Oy, its Vitacam software for measuring vital signs has now officially passed the EC conformity assessment and has been CE-marked as a medical device for immediate sales in Europe.
“CE marking is an important step for us on our journey from a software house to a medical device manufacturer. We started from an idea that was born in an innovation challenge at Oulu University Hospital. That led to a co-creation project called inDemand, funded by the City of Oulu. Collaboration with Oulu University Hospital has been pivotal for our company – complementing our strengths in computer vision and software development with deep clinical expertise,” says Miikka Kirveskoski, CTO of NE Device SW Oy.
Vitacam uses computer vision techniques to measure both the respiratory rate and heart rate. By tracking the movement of points on the chest area from a video sequence, the software can extract the respiratory rate. Heart rate is measured using remote photoplethysmography (r-PPG) whereby blood volume variations in the microvascular facial tissue are detected from a video sequence.
“While the potential for contactless measurement is widely recognised, very few solutions are approved for clinical use with the appropriate classification. We are excited by the potential improvement to patient safety and quality of care, across Europe and beyond,” adds Kirveskoski.
The EC conformity assessment was conducted by SGS Fimko according to the Medical Device Directive (93/42/EEC) of the European Union. The assessment was preceded by ISO 13485:2016 certification of the NE Device SW Quality Management System in December 2020.
CTO of NE Device SW
NE Device SW Oy is a software company from Oulu, Finland. It specialises in software for imaging and medical devices. Its flagship product ‘Vitacam’ uses computer vision to obtain vital signs measurements. It supports nurses by automating the routine task of gathering observations and has the potential to enable these observations in other contexts such as care homes.
SGS is the world’s leading inspection, verification, testing and certification company. The company is recognized as the global benchmark for quality and integrity, with more than 89,000 employees spread across a network of more than 2,600 offices and laboratories around the world.