FDA issued an “innovation challenge” Jan. 12 asking companies developing devices for end-stage renal disease to volunteer for a pilot program designed to assess new statistical tools and collaborative processes that the agency hopes will accelerate product development.
FDA’s device center is looking for a few firms focused on next-generation devices for managing end-stage renal disease to help it test new tools and processes designed to jumpstart early-stage product development.
One company has already said it wants to participate.
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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.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
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.
