Regulatory: Page 289

FDA extends MQSA certification for NY facilities
By AuntMinnie.com staff writers
Mammography facilities in the immediate vicinity of New York City’s World Trade Center will be able to maintain their accreditation and certification, even though some personnel have been unable to complete their continuing education (CME/CEU) requirements due to circumstances related to the September 11 terrorist attacks.
October 17, 2001
FDA approves Medtronic biliary stent
By AuntMinnie.com staff writers
Medtronic has received Food and Drug Administration clearance for its Bridge SE biliary self-expanding stent delivery system.
October 15, 2001
Proceedings of the ACR/FDA Workshop on Fluoroscopy
Issued October 12, 2001
This October 1992 workshop in Washington, DC, offered strategies for improvement in performance, radiation safety and control of fluoroscopic procedures. Today the document became available in PDF format on the FDA's CDRH Web site.
October 11, 2001
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
Biosonix gets CE mark for FlowGuard
By AuntMinnie.com staff writers
Israel-based blood-flow technology developer Biosonix has received the European CE mark for its FlowGuard technology.
October 3, 2001
GE gets clearance for CT colonography
By AuntMinnie.com staff writers
GE Medical Systems has received Food and Drug Administration clearance for its CT colonography technique.
September 26, 2001
Proposed PET payment cuts could halt growth
By AuntMinnie.com staff writers
Drastically reduced reimbursement for PET imaging next year could severely hamper the modality's growth in the U.S., according to the Reston, VA-based Society of Nuclear Medicine.
September 25, 2001
Imagyn gets OK for breast biopsy system
By AuntMinnie.com staff writers
Imagyn Medical Technologies has received Food and Drug Administration 510(k) clearance for its 22-mm SiteSelect stereotactic breast biopsy system.
September 25, 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
FDA approves Marconi's Infinite detector
By AuntMinnie.com staff writers
Marconi Medical Systems has received Food and Drug Administration 510(k) clearance for Infinite Detector technology for its Mx8000 multislice CT scanner.
September 24, 2001
Acuson gets CE Mark for AcuNav
By AuntMinnie.com staff writers
Ultrasound vendor Acuson has received the CE Mark for its AcuNav diagnostic ultrasound catheter, allowing the firm to distribute AcuNav in the European Union.
September 24, 2001
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