The Memorial Sloan Kettering spin-out has received CE-IVD and UKCA marks for its artificial intelligence software designed to identify HER2 expression in biopsies.
Just over a month since its seventh CE mark for its prostate cancer biomarker suite, Paige AI has collected its eighth, this time for its HER2Complete software, the company announced on 23 June.
Paige's HER2Complete is the first CE-IVD and UKCA-marked AI tool designed to identify tumor tissue with HER2 (human epidermal growth...
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
