LivaNova Gets FDA 510(k) OK for New In-Line Blood-Gas Monitoring System

 LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading 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 and completed a successful limited commercial release in Europe, will now be available globally.

B-Capta’s innovative sensing technology provides accurate and continuous measurements that allow the perfusionist to quickly react to parameter changes. The system’s intuitive user interface reduces set-up time, aligning parameters to those of the hospital’s Laboratory Blood Gas Analyzer (ABL) and includes accurate oxygen partial pressure (pO2), a key measurement when performing Goal-Directed Perfusion (GDP).

"B-Capta significantly extends the in-line, blood-gas monitoring options available to our customers for continuous monitoring of key patient physiological parameters consistent with clinical guidelines during extracorporeal life support procedures," said Marco Dolci, LivaNova Senior Vice President, Global Operations and R&D. "Now integrated into our world-leading S5 HLM, the optical-based technology used for B-Capta provides accurate and reliable monitoring of patient blood gas parameters."

https://finance.yahoo.com/news/livanova-receives-fda-510-k-130000120.html