Witapp’s mission, the third leading company of JSB Solutions’ Medical Device Virtual Talk, is to support doctors, technicians and healthcare professionals through its flagship medical device: Verima, the 3D reconstruction software of CT and MRI exams that allows the visualization of the reports in the form of hologram.
Verima: 3D and augmented reality for diagnostics and surgery
Verima allows the fusion of multiple images from the results of a patient’s examinations, all of which belong to a single diagnostic technique or the result of different techniques. Cross-referencing analyses from a CT scan repeated several times to analyse over time the evolution of the disease or analyses from a CT scan and an MRI scan, the software generates an image of the patient’s organ that can be viewed as augmented reality by an app on your smartphone/tablet or through mixed reality viewers.
But also as a manipulable, shareable, segmented hologram layer with which you can interact at a subjective level. The surgeon can see inside an organ, even in areas normally inaccessible to common diagnostic techniques, and display high-resolution images in which he can perceive the depth of individual details.
All a surgeon has to do is access a platform where they can upload a case and make holographic visions made to measure. Thanks to this technology, virtual images are brought into the real world.
Q&A: Questions from JSB Solutions to Witapp
1. According to the previous directive the device is class I, with the new regulation should have an upgrade to a higher class? “We find ourselves fully in this case, At the moment we are a class I device we have asked the problem both because it is a topic on the agenda and because the increasingly widespread use of the product in the operating room is opening up the issues ignored before. We started as a support to the surgical planning in reality the product is used almost exclusively in the room as support to the medical decision and to the guidance of the surgical operation”
Our focus on the “Grace Period” and the categories allowed
For the adaptation to the New Regulations of some Medical Devices there is a “Grace Period“, a period of grace that goes from 26 May 2021 to 26 May 2024.
In order to qualify for the transition period, the following conditions must be met:
- possess a device of which the EC certificate is valid. Certificates issued by bodies notified in accordance with Directives 90/385/EEC and 93/42/EEC as from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from the date of issue. However, they shall cease to be valid by 27 May 2024 at the latest
- be provided with a declaration of conformity drawn up before 26 May 2021
- there has been no significant change in the design and intended use of the device
In contrast, the period does not apply to devices with the following characteristics:
- class I devices that do not comply with the MDR reclassification
- class I devices on which significant changes have been made in the design or intended use according to the MDD certification once the MDR is fully operational
- any new Class I device developed and marketed after 25 May 2021
During the grace period, the MDR requirements for:
- post-market surveillance
- monitoring the market
- monitoring and supervision
- registration of economic operators and devices.
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