14 March 2017
BodyCap’s ingestible connected pills that enable wireless medical monitoring have been approved for use in Europe.
The e-Celsius Performance has been awarded the medical CE mark from Paris-based medical device assessment body and certifying organisation, LNE/G-MED.
French company BodyCap specialises in miniaturised wireless monitoring devices for e-health applications. Its e-Celsius is a class IIb medical device which allows continuous measurement of the patient’s central temperature by gastrointestinal tract.
The disposable electronic capsule is coated in a biocompatible medical grade plastic, and follows the intestinal transit after being swallowed by the patient.
The pill uses 433MHz frequencies to wirelessly transmit internal temperature measurements every 30 seconds. The readings are sent to a monitor called an e-Viewer which can be up to one metre away. The data show alerts when the measurement is outside the range set by the healthcare professional.
BodyCap says 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. Each e-Celsius pill is provided in standby mode. When the device is ready to be used, an activation box wakes it up and links it to the e-Viewer for data collection in real time mode, or by recovery from the pill’s internal memory with no loss of data, says BodyCap.
It adds that each device can store up to 2,000 data events and can remain operational for up to 20 days, but leaves the patient’s body naturally after one to three days.
BodyCap co-founder Sébastien Moussay believes the e-Celsius is a genuine alternative to the current use of rectal or oesophageal probes which are uncomfortable, generate stress and limit the patient’s mobility.
“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.”BodyCap says the e-Celsius Performance is already widely used in sports where it has been monitoring athletes since October 2015. It was used during the Rio 2016 Olympics and the New York Marathon.
Following its approval for hospital use in Europe, the device is now commercially available in countries that recognise the CE mark. As well as EU states, these also include other members of the European Economic Area – Iceland, Liechtenstein and Norway.
The e-Celsius will be sold directly or through specialised distributors for a unit price of €40 to €60 (£35 to £52), depending on volume.