EBR Systems (ASX:EBR) said the US Food and Drug Administration scheduled the manufacturing pre-approval inspection to start Jan. 14, according to a Monday filing with the Australian bourse.
The updated schedule does not affect the expected regulatory approval timing, which remains on track for the first quarter of 2025, with commercial launch later in the year, the filing said.
The inspection aims to confirm the company's manufacturing procedures are compliant with Quality System regulations and ensure consistent device production, according to the filing.
Shares rose nearly 7% in morning trade Monday and earlier reached an all-time high.
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