Zurich Medtech startup gets FDA clearance

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09.04.2024
Medical Templates CNS system

Medical Templates, the startup innovating the interventional radiology space, announced the receipt of the U.S. FDA clearance for its Cube Navigator software for planning of percutaneous, CT-guided interventions.

Navigation is gaining importance in the field of interventional radiology, mainly driven by expanding treatment options in oncology and improved patient outcomes through the use of minimally-invasive procedures.   Smaller targets, more complex access routes, and time and personnel constraints have all contributed to the increased adoption of CT navigation systems.

Medical templates, founded in 2017, is bringing intuitive, simple solutions in radiology and minimally invasive CT-guided interventions to market. Its Cube Navigation System (CNS) comprises a computer vision-enabled software that pairs with its proprietary hardware – a needle guide in the form of a Cube – as an alternative to free-hand navigation as well as capital-intensive solutions such as robots.

“Market pressures are pushing physicians to perform increasingly complex procedures, while reimbursement continues to be a driving force in determining which tools are used during interventions.  The Cube Navigation System was designed to provide accurate navigation at a reasonable price point, without compromising on workflow complexity or speed,” says CEO Anika Uhde.  “Centers in Europe have been enthusiastic about our solution because of its ease of use and incredibly fast onboarding. They see an improvement almost immediately.”

A recent study published in the Journal of Vascular and Interventional Radiology (JVIR) found that punctures performed with the Cube Navigation System were more than 4x closer to the target on the initial puncture, had significantly more accurate final needle locations, and were significantly faster.  Further studies on accuracy and speed are currently being carried out in Switzerland and Germany.

Parallel to the ongoing developments, the company's Cube Navigator software has been cleared by the US Food and Drug administration (FDA), cementing the company’s entry and launch in the U.S. market. 

(Press release/RAN)

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