The US Food and Drug Administration (FDA) has for French MedTech company BodyCAP鈥檚 connected medical device, eCelsius Medical System.
It is already used in the military and sports sectors and will now be adopted in the country for medical applications to measure a patient鈥檚 core body temperature for diagnostic or therapeutic purposes.
The Class II medical device is suitable for use in both clinical and research applications. Its current targeted areas comprise oncology and infectiology.
Integrated into a capsule that is simply swallowed, the thermometer allows for continuous and precise core body temperature measurements throughout the gastrointestinal transit until it is expelled.
The electronics are designed in-house by BodyCAP teams, encapsulated in a biocompatible material and sealed in a medical-grade PVC capsule. The capsule is phased out naturally by the patient.
Using the Medical eViewer monitor, the condensed technology communicates in real time at a frequency of 30 seconds. The monitor records data autonomously and sends alerts if thresholds are exceeded.
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By GlobalDataBodyCAP plans to commercially launch the system in January next year for medical use.
Temperature accuracy is 卤0.1掳C for the human physiological range of 36鈥�41掳C, while the communication protocol ensures data security.
BodyCAP co-founder and chairman S茅bastien MOUSSAY said: 鈥�The approval of our device for medical use is a major step in the company鈥檚 growth. It is the culmination of our investment in R&D and our expertise in monitoring physiological parameters more accurately in vivo, in real-time.
鈥淔or patients, the use of this device makes treatment more effective in several types of pathology, and we will continue to provide new solutions to optimise care and prevent complications.鈥�
