The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.
Regulatory and Compliance
FDA is alerting doctors and patients about the risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices.
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
It's the halfway point for the three-year transition period between the European Union’s old directive for regulating medical devices, and the new Medical Device Regulation.
A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.
The agency is encouraging innovation in digital health. But is software really so fundamentally different from hardware that it can’t be regulated in the same way?
Industry and FDA are working together to promote actual quality improvement, not just compliance to regulations.
Audrey Turley, of Nelson Labs, will speak at Medical Design & Manufacturing Minneapolis about biocompatibility issues related to medical devices including the move to more in vitro testing and the 2020 deadline for the new European Medical Device Regulation.
The decision to suspend its TempSure Vitalia system based on FDA concerns about vaginal rejuvenation procedures is expected to hurt Hologic's fourth-quarter revenue projections by $15 million.