Subjects: PDT, FDA
French MedTech BodyCAP launches its "eCelcius Medical System", a connected ingestible thermometer for medical applications in the United States.
PARIS, Oct. 4, 2023 /PRNewswire/ -- BodyCAP, a French MedTech company, has taken another step forward with the approval of its "eCelsius Medical System" connected medical device by the US Food and Drug Administration (FDA). This thermometer, integrated into a capsule that is simply swallowed, enables a continuous and accurate measurement of core body temperature throughout the gastrointestinal transit until it is expelled. Already widely adopted in the sports and military sectors, the eCelcius Medical System connected medical device will now be available in the United States for medical use to measure core body temperature in patients for diagnostic or therapeutic purposes (clinical research, infectiology, oncology, internal medicine).
A marker of infection, hyper- or hypothermia, core body temperature is an essential indicator in diagnosing a patient's state of health. Continuous, accurate measurement of this parameter is vital for the medical monitoring of patients in critical situations. However, until now, only a few restrictive devices, such as rectal or oesophageal probes, have been able to combine accurate and continuous monitoring of core temperature. To meet this need, French MedTech BodyCAP, based in Caen (Calvados), has developed the eCelsius Medical System, a Class II medical device that makes it possible to take this measurement to be taken in real time using a small, miniaturised electronic capsule - less than 2 cm long - that can be swallowed.
This condensed technology bundle communicates in real time at a frequency of 30 seconds with a dedicated monitor, the Medical eViewer, which records data autonomously and triggers alerts if thresholds are exceeded. Temperature accuracy is ±0.1°C for the human physiological range of 36-41°C and the communication protocol guarantees data security.
The full press release is attached.
About BodyCAP:
BodyCAP is a company that designs, develops, and markets wireless and miniaturised physiological measurement solutions. Founded in 2011, BodyCAP has developed expertise in ultra-miniaturised systems, embedded software and wireless communication. In particular, BodyCAP markets eCelcius Performance, a communicating electronic capsule dedicated to gastrointestinal core temperature measurement. BodyCAP operates in the sports, military, professional, clinical, and medical sectors. https://www.bodycap-medical.com
Logo - https://mma.prnewswire.com/media/2238450/BodyCap_Logo.jpg
PDF - https://mma.prnewswire.com/media/2238451/Full_Press_Release.pdf
SOURCE BodyCap
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