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apoQlar receives 510(k) Clearance for mixed reality surgical planning platform




German medical technology company apoQlar has received FDA 510(k) Class II clearance for VSI HoloMedicine.

The mixed reality software device enables surgeons to plan complex procedures using the power of immersive 3D holographic technology.

apoQlar will extend its distribution of VSI HoloMedicine in the US for clinical use through its subsidiary in Miami, Florida, with availability expected in the second quarter of 2023.

The company is now raising a Series A round, its first ever fundraising campaign, to scale VSI Holomedicine as the foundation of modern surgical care.

apoQlar co-founder and CEO, Sirko Pelzl, said:

“With mixed reality, we are no longer bound to physical objects in a physical world.

“We can leverage digital objects and services on top of the real world for equal or greater utility and usually at a fraction of the cost.

“Mixed Reality is a completely new way for people, and in our case surgeons, physicians and technologists, to continue to experience the real world around them but with an entire virtual layer placed on top.”

VSI HoloMedicine enables physicians to plan surgeries in 3D and visualise medical data inside or outside of the operating room.

Using Microsoft’s HoloLens 2, surgeons can transform otherwise flat CT, Angio CT, MRI, CBCT, PET, and SPECT sources into interactive 3D holograms to support the surgical process.

Sirko added:

“We are excited to finally offer VSI HoloMedicine to improve surgical outcomes for patients and to provide surgeons with sophisticated surgical planning tools to enhance their overall planning process.”

apoQlar COO, Liliana Duarte, said:

FDA clearance marks a major milestone for us.

“We are a young company, but this serves as a true testament of our collective team mindset and diligence.”

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