LivaNova Receives 510(k) Clearance for ECMO from FDA for LifeSPARC, the Next-generation Advanced Circulatory Support System

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Nov 17, 2022

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received 510(k) clearance for extracorporeal membrane oxygenation (ECMO) from the U.S. Food and Drug Administration (FDA) for LifeSPARC™, the Company’s next-generation Advanced Circulatory Support (ACS) pump and controller system. LivaNova leveraged existing real-world evidence inclusive of data collected during the COVID-19 pandemic to receive this new indication.