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‘Could be next Cochlear or ResMed’: heart device maker wins FDA approval

Michael Smith

EBR Systems, the heart device hopeful heavily backed by high-profile investors including, private equity veteran Mark Carnegie and big superannuation funds, has secured approval from authorities in the United States to begin selling its technology within months.

The Food and Drug Administration approval means the company can begin generating revenues. Its wireless pacing system prevents heart failure, for which the market for treatments could be worth as much as $6 billion.

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Michael Smith is the health editor for The Australian Financial Review. He is based in Sydney. Connect with Michael on Twitter. Email Michael at michael.smith@afr.com

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    Original URL: https://www.afr.com/companies/healthcare-and-fitness/hesta-hostplus-backed-heart-device-maker-ebr-wins-us-fda-approval-20250414-p5lrgv