Mobile fluoroscopy machine, DR detector cleared for U.S. sales

Dave Pearson | | Radiology Business | Artificial Intelligence
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The FDA has approved Xoran’s Tron CT system, a full-body fluoroscopy system that is fully mobile, and Viewworks’s Vivix-S F series flat panel detectors for digital radiography.

The companies announced the developments Aug. 4 and 5, respectively.

Xoran Technologies CEO Misha Rakic says the Tron system can be transported offsite by “placing it in small vans, lending Tron to low-dose screening brought to patients and not the other way around. This means that Xoran’s Vehicle-Based Solutions can be used for community health initiatives and in ambulance and military front-line scenarios.”

Xoran is based in Ann Arbor, Mich. News release with photo here.

Vieworks says its VIVIX-S F series represents the South Korean company’s “premium static X-ray DR flat panel detectors equipped with advanced technology and cutting-edge hardware design.”

The company is offering the detectors in three sizes.  

News release with photo here.

Other Recent FDA Approvals of Note:

FDA clears AI assessor of stricken dense brain tissue
FDA gives nod to MRI acceleration software equipped with AI
FDA grants IDE clearance for next-phase trial of ‘Flash’ radiation therapy
3D hologram system for guiding precision surgery gets FDA nod
FDA clears 3D print application for head/face and ortho structures
Image-guided spinal surgery system cleared
Pulmonary embolism AI cleared
FDA greenlights expansion of CT-guided, robotically supported IR system
Implantable heart stimulator conditionally cleared for MRI
FDA clears spinal-tap test that could challenge PET in Alzheimer’s diagnostics
Dave Pearson
Dave Pearson

Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.

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