Saluda Medical (ASX:SLD) said the US Food and Drug Administration (FDA) approved its CAP24 surgical paddle lead, an alternative to percutaneous leads, allowing them to be marketed and sold in the US for spinal cord stimulation, according to a Thursday Australian bourse filing.
The firm plans a phased US launch beginning in the second half of the year, with a broader commercial rollout starting later in the year.
Its shares soared 18% in recent trading on Tuesday.
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