FDA: Page 31

Imaging Diagnostic Systems gets Mexican install
By AuntMinnie.com staff writers
Laser breast imaging developer Imaging Diagnostic Systems of Fort Lauderdale, FL, has installed its CT laser mammography (CTLM) system at the Instituto Nacional de Cancerologia in Mexico.
October 9, 2001
Final 510(k) approvals for September 2001
Issued October 5, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for September 2001.
October 4, 2001
Fischer joins short list of FDA-approved digital mammography vendors
By Erik L. Ridley
Fischer Imaging has received Food and Drug Administration clearance for its SenoScan full-field digital mammography system, joining GE Medical Systems as one of two vendors able to sell an FFDM system in the U.S.
September 25, 2001
Hologic's new CEO takes aim at digital mammography
By Robert Bruce
Hologic CEO John Cumming will never be accused of being passive. Just two weeks after taking over as CEO, Cumming laid off 10% of Hologic's 350 employees and announced the Bedford, MA-based vendor's intent to achieve the top position in digital mammography.
September 17, 2001
Colorado MedTech reports progress with FDA
By AuntMinnie.com staff writers
Medical devices and outsourcing services firm Colorado MedTech is reporting progress in resolving its regulatory issues with the Food and Drug Administration.
September 16, 2001
Final PMA approvals for August 2001
Issued September 12, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for August 2001.
September 12, 2001
Final 510(k) approvals for August 2001
Issued September 7, 2001
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for August 2001.
September 6, 2001
FDA's proposed 'globally harmonized' PMA alternative
Updated July 25, 2001
This draft guidance document describes the Food and Drug Administration's proposed pilot program to evaluate a globally harmonized alternative for premarket procedures.
July 24, 2001
Fischer’s SenoScan closes in on FDA PMA approval
By AuntMinnie.com staff writers
Denver x-ray and mammography developer Fischer Imaging received an approvable letter from the FDA on its premarket approval (PMA) application for the SenoScan digital mammography system.
July 22, 2001
Deus gets clearance for lung-cancer CAD
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has granted premarket approval (PMA) to Deus Technologies of Rockville, MD, for its RapidScreen RS-2000 computer-aided diagnosis system for lung cancer screening.
July 12, 2001
CTI submits final module of PMA application
By AuntMinnie.com staff writers
Thermal imaging developer Computerized Thermal Imaging has submitted the fifth and final module of its premarket approval (PMA) application to the Food and Drug Administration for its Breast Cancer System 2100.
June 17, 2001
Fischer shuffles sales, service operations
By AuntMinnie.com staff writers
Mammography firm Fischer Imaging has reorganized its sales and service field operations in an effort to focus its energies on breast care.
May 23, 2001
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