Insulet Corporation has recalled its Omnipod 5 App for Android smartphones due to a software error that could throw off the accuracy of insulin dosing by as much as one hundred times the intended amount.
The US Food and Drug Administration has designated a November recall of Insulet’s insulin delivery app class I, its most serious type.
The recalled Omnipod 5 App is an Android-based software provided either on a locked-down controller or through Google Play on...
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.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
