EBR Systems Says US FDA Completes Inspection of New California Facility; Shares Up 4%

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EBR Systems Says US FDA Completes Inspection of New California Facility; Shares Up 4%

MT Newswires Live10:22

EBR Systems (ASX:EBR) said the US Food and Drug Administration (FDA) has completed its inspection of the company's new California manufacturing facility, according to a Monday filing with the Australian bourse.

The inspection was carried out in relation to the company's pre-market approval supplement to add the facility as a manufacturing site for the WiSE System, its lead-less left ventricular endocardial pacing device designed for cardiac resynchronization therapy in heart failure patients, the filing said.

The US FDA investigator issued a Form FDA 483 listing two routine observations, which the company has "promised to correct."

Facility approval is anticipated by year-end, per the filing.

EBR Systems shares rose 4% in morning trade Monday.

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