EBR Systems Secures ISO Certification for New US Manufacturing Facility; Shares Up 4%

MT Newswires Live

Sep 07

EBR Systems (ASX:EBR) has secured International Organization for Standardization (ISO) 13485 certification for its new Santa Clara manufacturing facility following an assessment by the British

Standards Institution, marking a key milestone in the company's quality and operational capabilities, according to a Monday filing with the Australian bourse.

The expanded facility's automated assembly machinery is expected to increase Wireless Stimulation Endocardially system production capacity by around 500%, while improving efficiency, reducing costs, and supporting the company's US commercial expansion, the filing said.

The US Food and Drug Administration pre-approval inspection is scheduled for September, with facility approval anticipated by year-end, the filing added.

The company's shares rose 4% in recent Monday trade.

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