FDAnews
www.fdanews.com/articles/162651-mri-interventions-siemens-to-commercialize-software-platform-for-mri-guided-catheter-procedures
Brain Scan

MRI Interventions, Siemens to Commercialize Software Platform for MRI-Guided Catheter Procedures

February 24, 2014

MRI Interventions and Siemens Healthcare Monday announced plans to co-develop and commercialize a next-generation software platform that will enable catheter-based procedures to be performed under real-time magnetic resonance imaging guidance.

The ClearTrace software platform will be used in combination with companion MRI-guided catheters, enabling procedures to be performed with minimal invasion under MRI guidance instead of the current fluoroscopic guidance — a technique utilizing X-rays.

The two companies initially partnered in 2009 to develop a research platform. Under Monday’s agreement, MRI Interventions will develop a commercial version of the research platform and, once completed, sell the software as its own product.

David Carlson, the company’s chief financial officer, told Device Daily Bulletin, declined to give a projected regulatory timeline for the ClearTrace system. The company’s first product, the ClearPoint Neuro Intervention System, is currently used in the U.S. and EU for MRI-guided, minimally invasive brain surgery.

Similar to ClearTrace, the ClearPoint system is an integrated platform of software, reusable hardware and disposable devices that provides surgeons with real-time, 3-D visualization with no radiation exposure to the patient or physician.

“We are pleased to continue our strong working relationship with MRI Interventions,” said Robert Krieg, vice president for MR product innovation and definition at Siemens Healthcare. “We see tremendous potential to improve patient care by further expanding the therapeutic uses of MRI.” — Nick Otto

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.