EBR Systems Plans FDA Label Update for WiSE System in Q4

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EBR Systems (ASX:EBR) plans to submit a changes being effected (CBE) premarket approval supplement to the US Food and Drug Administration (FDA) in the fourth quarter to proactively update the WiSE System's commercial labelling, with greater emphasis on echo-induced pacing risks and mitigation strategies, according to a Wednesday filing with the Australian bourse.

The company said it met with the FDA to discuss the plan, responded to the regulator's questions, and secured agreement on the proposed approach, per the filing.

The CBE pathway will enable labelling safety enhancements to be implemented during the review process, helping support patient safety as commercial rollout of the WiSE System expands, the filing added.

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