imitoWound 3.0

Intended Use

Our app imitoWound 3.0 and its server and web components are designed for health care professionals for the purpose of documenting wounds & stomas (digital wound documentation). It is intended for medical and medico-administrative documentation (storage & archival), communication, simple search and data representation/embellishment.

The main features include:

• Simple search
• Photo capturing with image calibration (calibration markers or rulers support)
• Documentation of wound size, based on photographs
• Documentation of wound status and therapy
• Storage, transfer and archival of data to the EMR (integration to EMR)

EU and Switzerland

imitoWound 3.0 is not a medical device as per “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” according to its intended use.

imitoWound 3.0 and its server and web components are intended for medical and medico-administrative documentation and data representation, and therefore, is not regulated by the European Union MDR.

US

In the US, imitoWound Enterprise is available solely for clinical investigational and research use.

Australia

According to the guidance issued by the Australian Therapeutic Goods Administration (Department of Health), “Examples of regulated and unregulated software (excluded) software-based medical devices,” Electronic Patient Records (EMRs) and Electronic Health Records (EHRs), i.e. software used to electronically receive, collect, store, manage, display, output, and distribute data within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data, are not medical devices and are not subject to any TGA regulatory requirements. imito programs function as part of EMRs / EHRs and provide the same functionality and thus are not enforced by TGA to comply with the regulatory controls.

South Africa

According to the “Guideline on Questions and Answers: Licensing of Medical Device Establishments” issued by SAHPRA, a medical device is any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent- (a) used or purporting to be suitable for use or manufactured or sold for use in- (i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or (ii) restoring, correcting or modifying any somatic or psychic or organic function; or (iii) the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or (b) declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device. imito programs are designed solely for the purpose of storing, transferring, converting formats, and displaying medical device data or medical imaging data and thus are not enforced by SAHPRA to comply with the regulatory controls.

Mexico

According to the guidance published by the Mexican Ministry of Health, patient data management and image management systems are not considered medical devices.  imitoWound functions as a patient data (including images) management system and is not enforced to comply with the regulatory controls.

India

In India, imitoWound Enterprise is available solely for clinical investigational and research use.

imitoCam

Intended Use

Our app imitoCam and its server and web components are designed for health care professionals for the purpose of enriching medical documentation with photos and videos. It is intended for medical and medico-administrative documentation and data representation.

The main features include:

• Documentation of clinical pictures & movies, wounds (digital photo documentation).
• Documentation of the size of wounds or other medical issues, based on photographs
• Storage, transfer and archival of data to the EMR (integration to EMR).
• A communication system for Healthcare Professionals (commenting & mentioning).
• Communication for DICOM modalities (Easy DICOM worklist).
• Simple search support (Picture: manual tagging & search).

EU and Switzerland

imitoCam is not a medical device as per “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” according to its intended use.

imitoScan

Intended Use

Our app imitoScan and its server and web components are designed for healthcare professionals and healthcare administrators for the purpose of maintaining complete patient documentation.

Its main feature is:

• Scanning and archiving of medico-administrative reports and documents.

imitoMeasure

Intended Use

Our app imitoMeasure is designed for digital photo documentation of various medical conditions and area measurement where it is relevant.

Its main features are:

• Documentation of wounds, dermatological lesions, specimens, etc as a PDF file
• Documentation of the size of medical conditions, based on photographs

Cutimed Wound Navigator

Intended Use

The app is intended for documentation (storage & archiving / filing), communication, simple search and data representation/improvement. It does not recommend products, but only filters Essity products from an Essity product catalogue based on the input of the health care professional. This output is afterwards open to the interpretation of the respective health care professional.

EU, Switzerland, and other Countries

The app is not a medical device according to EU MDR & and other internal laws (i.a. RSA, Australia, Canada and beyond) because of its intended use.