OncologyKai Sensors Receives FDA Clearance For Its Wireless, Non-Contact Respiratory Device
Hawaii-based Kai Sensors announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kai Sensors Non-Contact Respiratory Rate Spot Check, also called the Kai RSpot. The 510(k) clearance allows Kai Sensors to market the Kai RSpot to physicians, hospitals, and clinics.
The Kai RSpot is a device that offers a practical and effective approach of measuring respiratory rate in hospital and clinical settings. The device is easy to use and works wirelessly, with no contact or attachment to the patient.
Due to difficulties with current approaches of measuring respiratory rate, this important vital sign is often measured infrequently, inaccurately, inconsistently, or not at all. The clinically tested Kai RSpot provides a solution that addresses many of the shortcomings of existing technologies, and will enable doctors and health care professionals to measure a patient"s respiration with greater ease and with increased regularity.
"The 510(k) approval from the FDA is a major milestone for Kai Sensors that will enable our Company to continue to grow," said Kai Sensors CEO Andrea Yuen. "We believe the Kai RSpot will make collecting respiratory information easier for physicians and clinicians and thus help increase the amount of information available about a patient and improve the overall quality of health care."
Kai Sensors, Inc.