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Medical Devices / Inspections and Audits

FDA Warns Total Thermal Imaging for Unapproved Screening Device

Feb. 27, 2019

The FDA warned La Mesa, California-based devicemaker Total Thermal Imaging for marketing an unapproved device for breast cancer screening.

The agency rapped the company for marketing its Thermography Business Package as a sole screening device for breast cancer and other diseases. The company’s website and brochures claimed the product is intended for early detection and diagnosis of diseases including breast cancer, heart disease, deep pain thrombosis and reflex sympathetic dystrophy/complex regional pain syndrome.

The firm lacked the required premarket approval to sell such devices and it had not notified the FDA of its intent to distribute it, the agency said.

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