FDA clears portable photon-counting CT scanner
The U.S. Food and Drug Administration just cleared a portable photon-counting CT scanner designed for point-of-care settings.
New Zealand-based medical technology company MARS Bioimaging announced the 510(k) clearance of its MARS Bioimaging Extremity Scanner System on Tuesday. The photon-counting scanner is designed specifically for upper extremities and is intended for outpatient clinics, sports medicine practices and urgent care settings.
The portable scanner offers 3D, high-resolution images that enable physicians to clearly visualize soft tissues, bones, blood vessels and metallic implants. It can be used to help plan surgeries and has postop utility as well.
The Medipix3 technology this scanner harnesses was originally developed through particle physics research at the European Laboratory for Particle Physics (CERN). CERN gave MARS Bioimaging the exclusive license needed to commercialize the technology for medical imaging purposes.
“With FDA clearance, we can now scale clinical adoption of our scanners in the United States, the world’s largest CT market,” Chris Stoelhorst, chairman of MARS Bioimaging, said in a statement March 24. “This milestone supports our mission to enhance health economics and equity by expanding access to premium photon-counting CT imaging in community-based settings.”
Read more about the clearance here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.