IX-DR of Howell, MI, has received Food and Drug Administration clearance for its Mark I Thermal Imager thermography camera. The device resembles a small video camera, and uses thermal imaging technology to capture a monochrome image that is then colorized automatically, according to the vendor.
IX-DR sees the imager’s primary function as an adjunct to mammography. In the product’s 510(k) clearance letter, the company states that thermal imaging can demonstrate temperature variances in the breasts that can be used to clarify findings indicated by mammography or another imaging modality. Such temperature variances can be caused by the neoangiogenesis that accompanies tumor growth.
IX-DR will be sold in the near future for about $20,000, including hardware and software, through a dealer network.
By AuntMinnie.com staff writers
March 14, 2003
Related Reading
New adjunctive breast techniques improve positive biopsy rates, February 25, 2003
Start-up firm Photonify sees promise in optical imaging, January 14, 2003
Thermal breast-imaging device fails to win FDA advisors' support, December 1, 2002
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