FDA: Page 32

Hologic files PMA for Lorad digital mammography system
By Erik L. Ridley
Hologic has moved closer to its goal of commercializing a full-field digital mammography system. The Bedford, MA-based vendor has filed a premarket approval application with the Food and Drug Administration for its Lorad charge-coupled device (CCD)-based unit.
May 3, 2001
CAD startup Deus seeks clearance for lung-cancer device
By Kate Madden Yee
Computer-aided detection (CAD) technology may soon be deployed for lung cancer screening, if Maryland startup Deus Technologies has its way. The company has filed a PMA application for its RapidScreen RS-2000 lung cancer CAD unit.
April 19, 2001
Magna-Lab submits 510(k) for Cardiac View surface coil
By AuntMinnie.com staff writers
Niche MRI developer Magna-Lab has submitted a 510(k) application to the Food and Drug Administration for its Cardiac View surface coil.
March 19, 2001
Final 510(k) approvals for February 2001
Updated March 16, 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 February 2001.
March 15, 2001
Fischer files PMA for SenoScan full-field digital mammography system
By Erik L. Ridley
The U.S. digital mammography market may soon gain another participant. Fischer Imaging has submitted a premarket approval (PMA) application to the Food and Drug Administration for the company's SenoScan full-field digital mammography system.
March 14, 2001
Final PMA approvals for February 2001
Issued March 6, 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 February 2001.
March 5, 2001
CTI adds new sales VP
By AuntMinnie.com staff writers
Computerized Thermal Imaging has appointed Michael Giallongo to the newly created position of vice president, eastern U.S. regional sales operations.
February 28, 2001
Final PMA approvals for December 2000
Issued January 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 December 2000.
January 11, 2001
Imaging Diagnostic sells three CTLM units
By AuntMinnie.com staff writers
January 11, 2001
Final 510(k) approvals for December 2000
Issued January 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 December 2000.
January 4, 2001
FDA Guidance on submitting a 510(k) for wireless telemetry medical devices
Issued December 12, 2000
This document provides direction to manufacturers on deciding when to submit a 510(k) for a change to their existing wireless telemetry medical device or to a medical device incorporating wireless telemetry as a feature.
December 11, 2000
Final PMA approvals for November 2000
Issued December 12, 2000
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 November 2000.
December 11, 2000
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