Proving the Business Case for the Internet of Things

Bodycap connected pill receives CE mark

Steve Rogerson
March 28, 2017



An ingestible connected pill that enables monitoring of the body’s core temperature has received the CE mark meaning the Bodycap device will be commercially available in countries that recognise the certification.
 
The French company specialises in miniaturised wireless monitoring devices for e-health applications. The medical CE mark from the LNE Gmed certifying organisation means the e-Celsius device will be for sale in the European Economic Area, Iceland, Liechtenstein and Norway. It will be sold directly or through specialised distributors for a unit price of €40 to €60, depending on volume.
 
The class IIb medical device allows continuous measurement of the patient’s central temperature in the gastrointestinal tract. The disposable electronic capsule is coated in a biocompatible medical grade plastic. When swallowed by the patient it follows the intestinal transit. Every 30 seconds, the pill wirelessly transmits internal temperature measurements to a monitor called e-Viewer. This shows alerts when the measurement is outside the range set by the healthcare professional. The pill leaves the body naturally after one to three days.
 
The central temperature of the patient is one of the variable measures most regularly used during diagnosis or therapeutic follow-up in hospitals. It can detect an infectious peak, monitor the course of a fever or prevent the risk of hypothermia. Continuous monitoring of the patient's temperature is carried out in many situations:

  • During major surgery, involving prolonged general anaesthesia and post-operative follow-up;
  • During ambulatory surgery, for continuous temperature monitoring;
  • In general medicine, for diagnostic purposes;
  • In tropical medicine or infectiology, for faster management of pandemics;
  • While treating immunosuppressed patients or those at high risk of infection (sterile rooms);
  • During follow-up of chemotherapy treatments, to manage the side effects better; and
  • During sleep disorder analysis.
The performance and reliability of the device have been validated in clinical trials. The studies demonstrate the heat homogeneity of the gastrointestinal tract and the equivalence with data from rectal and/or esophageal probes, currently considered to be gold standards within hospital settings. The tests have also shown that device has a positive impact on patient and medical personnel wellbeing.
 
“The e-Celsius device is a true alternative method to the current use of rectal or eosophageal probes, which are invasive, uncomfortable, generate stress and limit the patient’s mobility,” said Sébastien Moussay, co-founder of Bodycap. “Our device is less intrusive and requires less from the medical staff, while at the same time increasing the well-being of both patients and healthcare personnel by lightening the workload. With the internal memory embedded in each capsule, e-Celsius ensures the monitoring of the patient's temperature kinetics in real time or deferred time, whatever the measurement conditions.”
 
The device is already widely used in the field of elite sports and has been monitoring athletes since October 2015. It has been used during major events such as the Rio 2016 Olympics and the New York Marathon. The company’s technologies have recently been used aboard the International Space Station as part of the Proxima mission.
 
Bodycap subscribes to a quality management process based on ISO13485 and ISO9001 standards. E-Celsius was developed with partners Lacroix Electronics and Asica. Fabrice Verjus, doctor of electronics, and Sébastien Moussay, doctor of sports science, founded Bodycap in 2011. The company is based in Caen, France. It has an exclusive licence for using a Philips patent and owns two other patents.