HoloCare is transforming how clinicians engage with medical images with interactive, easily generated holograms to give clinicians a clear 3D view of patient anatomy with our CE approved platform.

Medical imaging like CT is widely used at hospitals both for pre-operative surgical planning of patients, and planning of surgeries. However, understanding the anatomy and pathology only using CT is very dependent on the clinician experience and expertise, leading to more time spent on getting a common understanding of the patient case at hand to determine the best surgical procedure.

Using mixed reality, the surgeons can get a spatial view of the liver, lesions and blood vessels and use intuitive resection planning tools to help develop precise tissue saving plans. The HoloCare platform uses AI to segment patient specific DICOM images and seamlessly translates them into easily editable 3D models to be used in multi disciplinary team (MDT) meetings prior to surgeries.

Important

The platform is currently approved for non-diagnostic pre-operative planning by trained Gastrointestinal (GI) surgeons within liver surgery on adult patients with colorectal cancer liver metastasis.

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Intended Use

The HS2 is a cloud based, standalone, medical device software (SaMD). The HS2 is intended to be used as an adjunct to aid in the existing routine planning of surgical resection in the liver. HS2 translates CT data input of a patients’ liver, into inferred 3D models for the purpose of 3D visualization and interaction. HS2 includes functionalities such as 3D image review, image orientation, and rescaling.

HS2 is intended to be used as an adjunct to aid in the existing routine planning of surgical resection in the liver within a hospital environment. Not intended for primary diagnosis.

Indication and Patient Population

HS2 is intended for use with adult patients with colorectal cancer liver metastasis.

The patient has no direct interactions with the user interface.

The system is to be used to generate 3D visualization models that provide a preliminary segmentation of structures listed below:

Parenchyma preliminary segmentation
Blood vessels preliminary segmentation

Population of users

The users of HS2 are intended to be Gastro-Intestinal surgeons. These users are characterized by their educational background, cognitive capabilities, and their intention for use of the device. Table 1a provides an outline of the role, abilities, education, and background requirements that are relevant to qualifying in the user population.

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