e-sensia MD
e-sensia MD is the medical device company of e-sensia, based in Paris. It is taking over Caducy, a medical device software that measures heart rate and respiratory rate from a short video of the face.
About e-sensia MD
e-sensia MD SAS was created by e-sensia to carry its medical device activities. Following the acquisition of the assets of i-Virtual SAS, it takes over the development, the support and the monitoring of Caducy.
Caducy
Transfer of the legal manufacturer in progress
The version of Caducy in service (1.3.8) is placed on the market under the EU certificate issued to i-Virtual SAS. Its instructions for use and its labelling are those issued by i-Virtual SAS.
The transfer of the legal manufacturer to e-sensia MD is in progress with the notified body. This page will be updated when it is completed.
Instructions for use
The instructions for use of Caducy are provided in electronic form (Regulation (EU) 2021/2226). They are also available in the software, under Menu > Instructions. Documents open as PDF files.
| Version | Published | Language |
|---|
All versions issued in electronic form since the CE certification, with their date of publication. These versions were issued by i-Virtual SAS.
Paper copy and other documents
Requests for instructions for use in paper form, for a version not available online, or for the technical documents for integrators can be sent to issue@e-sensiamd.com.
Contact
- Questions, problems, paper instructions for useissue@e-sensiamd.com
- Technical supportsupport@e-sensiamd.com
- Personal dataprivacy@e-sensiamd.com
- Report a vulnerabilitysecurity@e-sensiamd.com
The addresses given in the instructions for use of Caducy 1.3.8 (issue@i-virtual.ai, privacy@i-virtual.ai) remain valid and are handled by e-sensia MD.
Vigilance
Any serious incident which has occurred in connection with Caducy must be reported to issue@e-sensiamd.com and to the competent authority of the member state in which the user and / or the patient is established.