Flowflex Becomes First At-Home COVID-19 Antigen Test Cleared Through 510(k)
The test is among the first of a wave of products initially authorized for emergency use by the US FDA that are now pursuing traditional approval pathways to stay on the market.
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Two regulatory attorneys spoke to Medtech Insight about the most important steps to take before the public health emergency ends, as well as what enforcement tactics they expect to see from the FDA.
News We’re Watching: Biden Moves To Strengthen Supply Chain; More Medtech-Related Prosecutions; $5.5M Sepsis Grant For Siemens
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.
In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.