www.fdanews.com/articles/198098-clinical-computer-systems-fetal-monitor-cleared
Clinical Computer Systems’ Fetal Monitor Cleared
July 17, 2020
The FDA has granted Clinical Computer Systems 510(k) clearance for its OBIX BeCA fetal monitor.
The monitor uses a patented technology from Huntleigh Healthcare that detects and then tracks the fetal heartbeat.
The device features high-sensitivity ultrasound for use in antenatal and labor settings for mothers with difficult assessments, such as early gestation.