National Institutes of Health Director Francis Collins, an influential supporter of genomic research and applications, says he has been urging FDA to take a "more aggressive role" in overseeing direct-to-consumer genetic tests
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A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.
Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
With a projected FDA submission within the next two to three years, Harbinger is prioritizing cancers based on lethality, prevalence, and unmet diagnostic need. Pancreatic and biliary cancers – often diagnosed at late stages and lacking established screening programs – will be among the initial targets.
