Regulatory: Page 284

CADx gets FDA OK for Second Look upgrade
By AuntMinnie.com staff writers
Computer-aided detection firm CADx Medical Systems has received Food and Drug Administration clearance for a supplement to its Second Look mammography CAD system.
May 21, 2002
Final PMA approvals for April 2002
Updated May 9, 2002
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 April 2002:
May 9, 2002
Given gets approved for new camera pill
By AuntMinnie.com staff writers
Israeli imaging developer Given Imaging has won FDA clearance for a new version of its novel camera-in-a-pill.
May 6, 2002
Proxima is cleared for MammoSite RTS
By AuntMinnie.com staff writers
Radiation-therapy developer Proxima Therapeutics has received FDA clearance for MammoSite RTS, a catheter-based radiation treatment device.
May 6, 2002
Final 510(k) approvals for April 2002
Issued May 6, 2002
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 April 2002.
May 5, 2002
CDRH organizational chart update
Issued May 2, 2002
The FDA's Center for Devices and Radiological Health (CDRH) works to ensure public safety by certifying the safety and effectiveness of medical and radiologic devices in the U.S. The CDRH organizational chart is updated quarterly.
May 5, 2002
CMS panel dashes hopes for PET Alzheimer’s payments
By AuntMinnie.com staff writers
A panel of the Centers for Medicare and Medicaid Services has affirmed a lower panel’s rejection of PET coverage for the diagnosis and management of Alzheimer’s disease.
April 21, 2002
AMR files 510(k) for film software
By AuntMinnie.com staff writers
American Medical Resources has filed for FDA clearance for its FilmSaver software, which is designed to help imaging facilities save money on film printing costs.
April 21, 2002
FDA clears Viatronix virtual colonoscopy product
By AuntMinnie.com staff writers
Another virtual colonoscopy product joins the field with the Food and Drug Administration’s clearance of the V3D-Colon hardware and software package from Viatronix.
April 18, 2002
GE, R2 get FDA approval for CAD with FFDM
By AuntMinnie.com staff writers
GE Medical Systems and R2 Technology have received clearance from the Food and Drug Administration to market R2’s ImageChecker CAD technology with GE’s Senographe 2000D full-field digital mammography (FFDM) system.
April 18, 2002
Konica to debut CR reader with larger exposure field
By AuntMinnie.com staff writers
The FDA has cleared the Konica Regius Model 350 computed radiography system.
April 17, 2002
Amex suspends trading of HealthCare Integrated Services
The American Stock Exchange has suspended trading of HealthCare Integrated Services’ common stock pending filing of the company’s 2001 10-K annual report.
April 17, 2002
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