News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope
This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.
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The companies will argue the deal is “pro-competitive and life-saving” at a US Federal Trade Commission administrative trial on 24 August, but the FTC maintains the deal will hinder innovation in the multi-cancer diagnostics market. The merger is also facing regulatory scrutiny in Europe.
IDA Ireland’s Rachel Shelly tells Medtech Insight about what is (and isn’t) driving investment in medtech.
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.