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[FEATURED] When Will EU Commission, Member States React To Calls For Extending Regulation Deadlines?
The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for […]Read More[FEATURED] Q3 US Device Approvals Snapshot: Apps Up, Original PMAs Down
Mobile apps made major headway into the world of US FDA regulation in the third quarter, with de novo go-aheads […]Read More[FEATURED] FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s
A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions […]Read More[FEATURED] First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised
There’s been progress toward designating notified bodies against the EU’s medtech regulations, but the developments need to be […]Read More[FEATURED] EU Post-Market Clinical Follow Up: What Manufacturers Need To Know
The EU’s new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. […]Read More