CTI Thermal Breast Imaging Device Will Go Before FDA Panel In Mid-October
This article was originally published in The Gray Sheet
Executive Summary
FDA's decision to bring Computerized Thermal Imaging's BCS 2100 thermal breast imaging system before an advisory panel upholds the integrity of the PMA filing and disproves allegations that the firm unlawfully tampered with the submission, according to CTI
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CTI BCS 2100
Breast imaging system will be evaluated in a new clinical trial at Massachusetts General Hospital beginning in the fall, the firm announces Aug. 21. The study will look at the non-invasive thermal imaging system as a follow-up to abnormal mammograms to distinguish between benign and malignant tumors. A PMA for the device is scheduled for review by FDA's Radiological Devices advisory panel on Oct. 16 (1"The Gray Sheet" July 29, 2002, p. 16)...
CTI BCS 2100
Breast imaging system will be evaluated in a new clinical trial at Massachusetts General Hospital beginning in the fall, the firm announces Aug. 21. The study will look at the non-invasive thermal imaging system as a follow-up to abnormal mammograms to distinguish between benign and malignant tumors. A PMA for the device is scheduled for review by FDA's Radiological Devices advisory panel on Oct. 16 (1"The Gray Sheet" July 29, 2002, p. 16)...
CTI Class Action Stems From Management Dispute On PMA Submission Timing
Alleged misrepresentations about the status of a pending premarket approval application for Computerized Thermal Imaging, Inc.'s BCS2100 breast cancer detection system are the subject of a recent 1shareholder class action lawsuit against CTI and former President and COO David Packer