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Latest From David Filmore
The Massachusetts-focused device industry trade group has appointed journalist Brian Johnson as its new president, replacing long-time leader Tom Sommer.
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, Stryker gets a go-ahead to enter the US flow diverter/aneurysm market, and nine CE marks are highlighted.
Part 3 of Medtech Insight’s feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed on this week’s podcast. Author Shawn M. Schmitt gives details on how Baxter Healthcare, Edwards Lifesciences and other firms weathered their appraisals using the Capability Maturity Model Integration (CMMI) model and method.
Durable medical equipment suppliers will have the flexibility to provide products to any Medicare beneficiaries without having to win a competitive bidding contract beginning Jan. 1. That state-of-play will last until CMS reinitiates the paused bidding program currently undergoing reforms.
Cook Group maintained strong 510(k) clearance numbers, while US FDA novel-device approvals picked up in Q2 after a slower first quarter. Here's an infographic to spotlight US device approval trends during the second quarter, April through June.
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.