Nihon Kohden Gets 510(k) for Early Detection, Notification System
Nihon Kohden America Inc. said its Prefense Early Detection and Notification System received 510(k) clearance from the FDA, paving the way for its release to customers.
Prefense is designed to protect hospital patients from medical harm and enhance the efficiency of rapid response teams. Prefense allows hospital patients to freely ambulate while measuring heart rate, blood pressure, oxygen saturation and respiration — four of the seven critical parameters that trigger a rapid response team. The device aims to provide continuous monitoring to reduce risk exposure among the large number of patients in med/surg wards.
The Prefense system consists of a new, low-acuity central station interface that is reportedly simple, easy to use and cost-effective, and is combined with the company’s NTX wireless telemetry transmitters. Future versions will also include pagers for nurses, rapid response team members and other caregivers in need of notification.