Corsano Health is announcing that its CardioWatch 287 is a CE medical device certified under EU-MDR standards.
Today, Corsano Health B.V., a leading MedTech company developing, producing, and marketing medical grade continuous health monitoring announced that it has received the European Union Medical Devices Regulations (EU-MDR) certification for its CardioWatch 287 remote monitoring system.
The CardioWatch 287 is a wireless remote monitoring system intended for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability (R-R interval), respiration rate, activity and sleep. Data is transmitted wirelessly from the device via the application or gateway to a health cloud where it is stored and made available for further analysis.
The CardioWatch 287 can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
Notified Body DARE!! Services B.V. declares that it has audited the quality assurance system in accordance with MDR Annex IX and that the relevant provisions of the Regulation 2017/745 dated May 5, 2017 concerning Medical Devices are fulfilled. The validity of the certificate is three years and includes the surveillance obligations of Annex IX, section 3. CardioWatch 287 is covered by the certificate and may bear the CE marking using the Notified Body number “1912”.
“This achievement is a major milestone for Corsano Health in its mission to provide Continuous Cardiac Monitoring, Anytime, Anywhere.” said Drs. Peter Stas, CEO of Corsano Health.