CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of medical products in 32 European countries. The certification, like the FDA stamp of approval, is needed before any medical device can be launched commercially.
Designed to monitor patients’ core temperature, the e-Celsius looks like and is ingested like a regular drug capsule. As it moves down the GI tract, every 30 seconds the device wirelessly transmits data to an ‘e-Viewer’ that displays the readings and records the temperature during the pill’s journey.It also sends alarms if temperature is under or above customisable thresholds.
Consistency of measurement
According to MedGatget, during studies the e-Celsius demonstrated consistency of measurements and the fact that the GI tract has a generally uniform temperature throughout. The readings have matched those taken rectally, while avoiding having to access regions untainted by the sun.
Once the pill makes its way through the GI tract, it is simply expelled along with everything else down there. The device goes out of the gastric system with an operational duration which depends on transit time.
The e-Viewer can be pre-programmed to issue warnings if the temperature moves outside of a set range. This can be important in fragile patients, including those with a compromised immune system that are at risk of infection. The device can also benefit clinicians watching over patients during lengthy surgeries, as well as during recovery.
The pill, when provided, is in standby mode. An activation box enables wake-up and association with monitor for data collection in real time mode or by recovery from internal memory of e-Celsius with no loss of data. A single monitor can be associated simultaneously with up to three pills, enabling extended uses.
Each pill will cost between €40 and €60 and comes with an activation box that’s used to engage the e-Celsius and partner it with a particular e-Viewer.