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Latest From David Filmore
Test-makers and labs say the agency is missing large swaths of the market in making its "market-based" lab payment calculation, but CMS stands by its data, and finalized 2018 lab fee schedule rates. Could next steps be in Congress, or the courts?
The agency authorized a next-generation sequencing tumor profiling system that leverages the New York State Department of Health to speed future clearances.
The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.
On this week's podcast, we discuss some cases that might come up in the current session of the US Supreme Court and have an important impact on the device industry – in the realm of patent reviews, and consumer and state lawsuits.
The global regulatory environment for devices and diagnostics is rapidly evolving, with new frameworks, rules and directives rolling out around the world. To help keep up during this period of fundamental change, Medtech Insight has launched a new interactive timeline.
Our "terrifying tales" of US FDA inspections that went awry attracted, by far, the most readers last month. Also popular in October: Medtech Insight's reporting on the US agency's move to bring its device evaluation, compliance and surveillance activities all under one roof, and our deep-dive look at the promise and challenges of applying artificial intelligence to quality operations.