CTI tries for incremental FDA approval
Computerized Thermal Imaging has submitted three of five data packages, or what the company is calling "modules," to the FDA as part of its premarket approval application for a breast cancer detection system that uses a heat sensitive camera. The
Computerized Thermal Imaging has submitted three of five data packages, or what the company is calling "modules," to the FDA as part of its premarket approval application for a breast cancer detection system that uses a heat sensitive camera.
The modules are data packages explaining to the FDA how the company's Computer Thermal Imaging system works. The system consists of a patient table and heat-sensitive camera and uses the company's proprietary computer algorithms.
The CTI camera can be used in conjunction with an x-ray mammography system, said Dee Rose, CTI spokesperson.
CTI was founded in 1987 by business partners who recognized that thermal imaging coupled with sophisticated software could differentiate healthy from suspicious tissue because of heat generated by the increased vascularity associated with tumors.
The firm believes that data generated by the CTI system can assist physicians in detecting the presence of numerous diseases, disorders, and injuries within the body's physiological, neurological, and vascular systems that conventional imaging systems such as x-ray, CT, or MR may miss.
The modules are being considered by the FDA in separate pieces. The first module was approved by the FDA at the end of last year. The second was submitted in February and is still under review.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
FDA Clears Virtually Helium-Free 1.5T MRI System from Siemens Healthineers
June 26th 2025Offering a cost- and resource-saving DryCool magnet technology, the Magnetom Flow.Ace MRI system reportedly requires 0.7 liters of liquid helium for cooling over the lifetime of the device in contrast to over 1,000 liters commonly utilized with conventional MRI platforms.
