Press release (MAR)
Malmö, Sweden November 25, 2020
Acarix receives US market approval for the CADScor System
Acarix AB (publ) today announced that the US Food and Drug Administration (FDA) has approved the company's De Novo application for marketing approval of the CADScorSystem in the US.
"This is a major achievement and a significant recognition of our technology and how it can improve the diagnosis of patients with potential Coronary Artery Disease". "In addition, it will contribute significantly to the value creation of Acarix. This approval enables us to take all measures to prepare the market launch in the USA." said Per Persson, CEO of Acarix".
The De Novo process is used for new products where there is no predicate device with a comparable indication in the US market to support a standard 510 (k) application. Acarix filed the De Novo application in November 2019.
For further information, please contact:
Per Persson, CEO, E-mail: per.persson@acarix.com, Phone: +46 73 600 59 90
The information disclosed above is mandatory for Acarix AB (publ) to publish pursuant to the EU Market Abuse Regulation. This information was submitted for publication through the agency of the above contact person on November 25, 2020 at 13:15 am (CET).
About Acarix:
Acarix was established in 2009 and is listed on Nasdaq First North Premier Growth Market.
Attachment
- PR_Acarix_DeNovo granted_Eng (https://ml-eu.globenewswire.com/Resource/Download/87f775cf-26e2-4439-86d3-f6603218d59e)
