FDA panel votes down CTI product

Article

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.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
Reducing Mammography Workload by Nearly 40 Percent? What a New Hybrid AI Study Reveals
 What New Research Reveals About Portable Low-Field MRI and Patients with Suspected Alzheimer’s Disease
Diagnostic Imaging's Weekly Scan: August 11 — August 17 (Video Version)
© 2025 MJH Life Sciences

All rights reserved.