LivaNova Earns FDA Clearance for Blood Gas Monitoring System
The FDA has granted LivaNova 510(k) clearance for its B-Capta blood gas monitoring system, a device that continuously monitors arterial and venous blood.
The system can continuously monitor blood during complex cardiopulmonary bypass procedures, the company said. It features a user interface that aligns the parameters to hospitals’ laboratory blood gas analyzers. The device, which does not require calibration at the start of procedures, provides visual and audio warnings when parameters fall outside of specified thresholds.
The B-Capta device received CE mark certification in May 2020 and had a limited commercial release in Europe.