Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.
LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.
LONDON – The European Commission offered up to €80 million (US$89.4 million) of funding to Curevac AG, to scale up development and production of a vaccine against the coronavirus in Europe, following reports that the U.S. administration had made an offer for the German biotech, in order to get exclusive control of its COVID-19 vaccine candidate.
BOSTON – The transition of the European med-tech regulatory system is not going well, but Oliver Bisazza, director of regulations at Medtech Europe, said device makers should nonetheless continue preparing product dossiers for recertification of existing CE marks because "you have to be able to show them you have been making an honest go of it" where re-certification is concerned.