Disior, a medical technology company focused on the development and commercialization of analytics software for medical doctors, announced it has received CE Mark approval (Medical Device Class IIb) for the foot and ankle analysis application.
“The CE mark approval is a significant milestone for Disior as it required thorough regulatory review against high clinical and safety standards”, said Anna-Maria Henell, CEO of Disior. “This is an important leap forward for our company, as we are bringing to market a novel and automated tool for analysing radiographic angles, measurements and reference points that we are confident will benefit both healthcare providers and patients.” This certification confirms that the product meets the international standard (ISO 13485:2016) for designing, developing, manufacturing and selling medical software for diagnostics and treatment planning. |