US FDA grants clearance for VR surgical planning software from Realize Medical

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Realize Medical has announced that its virtual reality (VR) software for surgical planning, Elucis, has received 510(k) clearance from the US Food and Drug Administration (FDA).

Elucis enables medical professionals to quickly create, understand, and share complex patient anatomy from computed tomography (CT) and magnetic resonance imaging (MRI) in an immersive 3D environment.

The virtual collaboration tool lets users connect with other users from within VR or through desktop PCs. The platform can be used to improve 3D pre-operative planning and patient consultations.

“Virtual planning with Elucis allows me to conceptualise innovative procedures with the end product of successful cases, development of new devices, and improved education for patients and families,” said Jenny Zablah (Children’s Hospital Colorado, Aurora, USA).

Current and planned use cases for Elucis are expected to align to the needs of surgeons across all disciplines.

“We’re often told that Elucis represents the most advanced offering in the mixed reality space. But with powerful image processing, modelling, and collaboration tools, it’s also a comprehensive and complete platform for serving the full suite of growing 3D needs in medicine. With FDA clearance, we’re truly excited to enable an expanding era of procedure planning and collaboration,” said Justin Sutherland, Realize Medical CEO.


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