• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

CTI tries for incremental FDA approval

Article

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.

Related Videos
Does Initial CCTA Provide the Best Assessment of Stable Chest Pain?
Making the Case for Intravascular Ultrasound Use in Peripheral Vascular Interventions
Can Diffusion Microstructural Imaging Provide Insights into Long Covid Beyond Conventional MRI?
Assessing the Impact of Radiology Workforce Shortages in Rural Communities
Emerging MRI and PET Research Reveals Link Between Visceral Abdominal Fat and Early Signs of Alzheimer’s Disease
Reimbursement Challenges in Radiology: An Interview with Richard Heller, MD
Nina Kottler, MD, MS
The Executive Order on AI: Promising Development for Radiology or ‘HIPAA for AI’?
Related Content
© 2024 MJH Life Sciences

All rights reserved.