Health Canada grants medical device license to Optomed handheld fundus cameras
OPTOMED PLC PRESS RELEASE 18 February 2020 at 9:00
Health Canada grants medical device license to Optomed handheld fundus cameras
Optomed received a medical device license from Health Canada in January 2020. This license allows Optomed to start commercial operations in the Canadian health care market. The license is valid for both, the Optomed Aurora handheld fundus camera as well as our OEM branded camera, Signal. Optomed cameras have previously been granted a similar medical device license (FDA) also in the US market. This Canadian registration now allows commercial activities throughout North America.
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
Optomed Vice President of the Devices segment, Laura Piila comments the registration: “Opening up new markets for our handheld cameras is one part of our growth strategy. This gives us, and our selected sales partners the possibility to start sales and marketing operations also in the Canadian market, which will help to increase awareness on our handheld cameras and support our global growth.”
Further enquiries
Laura Piila, Vice President, Devices, Optomed Plc, +358 40 588 1187, laura.piila@optomed.com
Optomed in Brief
Optomed is a Finnish medical technology company and one of the leading providers of handheld fundus cameras. Optomed combines handheld screening devices with software and artificial intelligence with the aim to transform the diagnostic process of blinding eye-diseases such as rapidly increasing diabetic retinopathy. In its business Optomed focuses on eye-screening devices and software solutions related R&D in Finland and sales through different channels in over 60 countries. The company has an extensive portfolio of 52 international patents protecting the technology. In 2018, Optomed’s revenue reached EUR 12.7 million and pro forma revenue with the acquisition of Commit; Oy amounted to EUR 14.5 million. At the end of September 2019, Optomed employed 105 professionals.