Regulatory approval received for a new product designed for the Chinese market
Optomed Plc Press Release 3 June 2020, 10.00, Helsinki
Optomed has received a regulatory approval for a new product designed for the Chinese market
Optomed has received a medical devices regulatory approval in China for a new camera product. This new product, Optomed Smartscope EY80, has a wider field-of-view, 80-degrees and it is designed for retinal screening of newborn babies and small children. Optomed believes that this is the first non-contact fundus camera approved in China for newborn imaging. This approval from the Chinese Food and Drug Administration (CFDA) allows Optomed to start commercial operation of this new product in China.
Optomed is still waiting for the Chinese CFDA approval for its flagship product, Optomed Aurora camera.
Laura Piila, Vice President Devices, Optomed Plc, +358 40 588 1187, firstname.lastname@example.org
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 over 50 international patents protecting the technology. In 2019, Optomed’s revenue reached EUR 15 million and 2018 pro forma revenue amounted to EUR 14.5 million. At the end of 2019, Optomed employed 108 professionals.