IVD DNA Test For Cancer Receives New Regulatory Classification
The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.
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A proposed rule from the US Food and Drug Administration would allow the agency to take on regulation of lab-developed tests by phasing out the previous approach of enforcement discretion
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.