A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 9-15 July was another slow one for US FDA approvals, with no new PMAs, panel-track PMA supplements, or de novos. Informa’s Meddevicetracker reported three non-US approvals during the week.
The US Food and Drug Administration did not approve any original PMAs or panel-track PMA supplements during the week of 9 July to 15 July.
During the week, the FDA approved 24 non-panel track PMA supplements, including a supplemental approval of MitraClip G4, the fourth-generation of
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
