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LIVN - FDA clears LivaNova's B-Capta a blood-gas monitoring system
LivaNova PLC
LivaNova (LIVN) has received FDA 510(k) clearance for B-Capta, the new blood-gas monitoring system integrated into S5 heart-lung machine ((HLM)).The system is designed to easily and accurately monitor arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures.B-Capta, which received CE Mark in May 2020, will now be available globally. LivaNova also received 510(k) clearance for its S5 PRO HLM.