An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the
An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the company's infrared breast imaging system. Panel members described the technology as promising but decided more clinical data were necessary for members to recommend approval. The FDA has yet to decide on the matter.
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Study Shows Enhanced Diagnosis of Coronary Artery Stenosis with Photon-Counting CTA
July 10th 2025In a new study comparing standard resolution and ultra-high resolution modes for patients undergoing coronary CTA with photon-counting detector CT, researchers found that segment-level sensitivity and accuracy rates for diagnosing coronary artery stenosis were consistently > 89.6 percent.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.