iXensor, a Taipei-based mobile health solutions developer, received a CE-IVD mark for its PixoTest POCT COVID-19 Antigen Test.
WHAT IT DOES
The point-of-care test is an end-to-end fully digitalised rapid screening solution. It comprises a palm-sized analyser, a digital health pass app, an admin app and a HIPAA-grade health management web portal.
iXensor said in a statement that its diagnostic...
Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus,...