Preview documents from the US FDA show the agency is aware of the mortality risk linked to paclitaxel-coated devices, but stop short of suggesting the devices be removed from the market.
An executive summary released by the US Food and Drug Administration ahead of next week’s cardiac devices advisory panel meeting on paclitaxel-coated cardiac devices recognizes an apparent increased death risk tied to the devices, but says more analysis is needed to further understand the issue.
The meeting, scheduled for 19 and 20 June, will continue a discussion of the safety of drug-eluting balloons and stents...
A late-August batch of device classifications from the US FDA includes genetic tests from 23andMe, hand-held spinal surgery tools, and several IVDs.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.
