NuVasive Recalls Orthopedics Implants Over Biocompatibility Concerns
The US FDA says the company has voluntarily issued a recall for Precice metal implants after reports of adverse events that could be related to the design of the product or biocompatibility issues.
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The FDA said the benefits of the devices, which are used to prevent spinal deformity in children with thoracic insufficiency syndrome, outweigh their known risks.
The agency has developed a user-friendly four-step process sponsors can use to address biocompatibility issues based on its 2016 biocompatibility guidance.
AdvaMed's top lobbyist says a new documentary critical of the medical device industry and US FDA's device review pathways is unlikely to result in Congressional action. However, the group is talking to members on Capitol Hill to make sure they fully understand the context within which devices are reviewed and marketed.