Actual text from Applied Radiology Abstract
In the press release, the doctor says that furthur research is needed. He didn't say that IMDS was ready for FDA submission. Here's why:
30% of the time that the CTLM looks at a malignant lesion, the CTLM will not suggest the lesion is cancer. 32% of the time when shown a benign lesion the CTLM will suggest it is actually cancer. Don't believe me? Look at the last paragraph of the abstract.
A diagnostic machine that is wrong that often has little to no chance at market acceptance let alone FDA approval. No wonder IMDS has not even begun clinical trials to replace the failed FDA PMA. Though it is a medical malpractice attornies' dream device LOL.
From June 2005 Diagnostic Imaging magazine:
Characterization of Benign and Malignant Breast Lesions With Computed Tomography Laser Mammography (CTLM): Initial Experience.
Investigative Radiology. Breast Imaging Part 1. 40(6):328-335, June 2005.
Floery, Daniel MD *; Helbich, Thomas H. MD *; Riedl, Christopher C. MD *; Jaromi, Silvia MD *; Weber, Michael PhD *; Leodolter, Sepp MD +; Fuchsjaeger, Michael H. MD *
Abstract:
Objectives: The aim of this study was to characterize benign and malignant breast lesions with computed tomography-laser mammography (CTLM).
Materials and Methods: In a prospective study, 100 female patients with 105 breast lesions classified as BIRADS IV to V at mammography underwent mammography, CTLM, and histologic verification at our institution. CTLM images were analyzed by radiologists with knowledge of the lesion's position but who were blinded to histology and morphologic findings from mammography. Two radiologists independently evaluated whether there was increased absorption, a sign of malignancy, on CTLM and assessed the appearance (volumes or linear branching) and shape (round or irregular) of the lesions.
Results: Histologic analysis revealed 55 benign (52.4%) and 50 malignant (47.6%) breast lesions. Increased absorption was observed significantly more often in malignant than in benign lesions (70.0% vs. 32.7%, P = 0.028). Invasive cancer showed increased absorption in 76.2%, and ductal carcinoma in situ in 37.5%. Common morphologic characteristics of increased absorption were "volumes" (85.7% of malignant and 77.8% of benign lesions) with round shape (78.1% of malignant and 73.3% of benign lesions).*