EBR Systems' US FDA Pre-Approval Inspection Set for January 2025; Shares Up 3%

MT Newswires Live

2024/12/19

EBR Systems (ASX:EBR) said its manufacturing pre-approval inspection with the US Food and Drug Administration has been set for the week starting Jan. 6, 2025, according to a Thursday filing with the Australian bourse.

The inspection aims to confirm that the company's manufacturing, processing, and packing procedures adhere to quality system regulations, ensuring consistent device production meeting approved specifications, the filing said.

The US FDA initiated a review for the company's pre-market approval submission in late September, with the upcoming day-100 meeting scheduled for Friday, according to the filing.

Shares rose nearly 3% in midday trade Thursday.

Price (AUD): $0.89, Change: $+0.03, Percent Change: +2.91%

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