Regulatory: Page 290

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
Sectra digital mammo system begins clinical trials
By AuntMinnie.com staff writers
Swedish PACS and medical technology developer Sectra's digital mammography system is scheduled to begin clinical testing at St. Göran's Hospital in Stockholm next month.
September 17, 2001
Biofield to try again with FDA
By AuntMinnie.com staff writers
Breast cancer diagnosis developer Biofield has met with the U.S. Food and Drug Administration as a first step towards renewing efforts to obtain clearance for its Biofield Diagnostic System.
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
Kodak to assist with MQSA accreditation
By AuntMinnie.com staff writers
Eastman Kodak has introduced a free program designed to help mammography clinics maintain accreditation mandated by the Mammography Quality Standards Act.
September 13, 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
HIPAA Summit posts free materials online
By AuntMinnie.com staff writers
The HIPAA Summit conference series has posted a series of faculty presentations and educational materials online regarding the Health Insurance Portability and Accountability Act.
September 12, 2001
Boston Scientific gets CE Mark for FilterWire
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received the European CE Mark for carotid applications of its FilterWire EX embolic protection device.
September 9, 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
Genentech gets approval for Cathflo Activase
By AuntMinnie.com staff writers
Pharmaceutical firm Genentech has received Food and Drug Administration approval for its thrombolytic agent Cathflo Activase.
September 5, 2001
DuPont's Definity echoes through contrast market
By Robert Bruce
DuPont Pharmaceuticals is preparing its U.S. launch of Definity, an ultrasound contrast agent that was cleared by the Food and Drug Administration in August. But the firm is reassessing its European application.
September 3, 2001
GE gets hip assessment clearance
By AuntMinnie.com staff writers
GE Medical Systems of Waukesha, WI, has received Food and Drug Administration 501(k) clearance to market its advanced hip assessment software package.
August 29, 2001
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