Regulatory: Page 260

Unfors gets nod for dosimeter
By AuntMinnie.com staff writers
Radiation calibration and measuring instrument firm Unfors Instruments has received Food and Drug Administration 510(k) clearance for its Patient Skin Dosimeter (PSD).
October 27, 2004
Medicsight gets FDA nod for Colon CAR
By AuntMinnie.com staff writers
Image analysis software developer Medicsight has received U.S. Food and Drug Administration marketing clearance for its Colon Computed Assisted Reader (CAR) 1.2 software.
October 26, 2004
Given gets U.S. OK for esophagus imaging device
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging has received marketing clearance from the U.S. Food and Drug Administration for its Given Diagnostic System, including the PillCam ESO video capsule for imaging the esophagus, according to the Yoqneam, Israel-based firm.
October 25, 2004
GE partners with InSightec
By AuntMinnie.com staff writers
GE Healthcare and noninvasive therapy technology developer InSightec have collaborated to introduce an MR image-guided focused ultrasound system.
October 24, 2004
ev3 stent gets 510(k)
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) marketing clearance for its Protégé GPS nitinol self-expanding long stent.
October 20, 2004
Advanced Magnetics, Cytogen get FDA nod
By AuntMinnie.com staff writers
MR contrast developer Advanced Magnetics and biopharmaceutical firm Cytogen said they have submitted a complete response to the approvable letter received from the Food and Drug Administration for Combidex, Advanced Magnetics' investigational molecular imaging agent.
October 19, 2004
ABR issues nuclear radiology update
By AuntMinnie.com staff writers
The American Board of Radiology (ABR) reported that the U.S. Nuclear Regulatory Commission (NRC) has delayed a final decision on proposed new regulations that govern the training and experience required to use radioactive materials commonly employed in clinical nuclear radiology until October 24, 2005.
October 13, 2004
CMS finalizes coverage for carotid artery stenting
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has expanded coverage of percutaneous transluminal angioplasty (PTA) of the carotid artery with stenting. The final national coverage determination (NCD) applies to Medicare-eligible participants of a Food and Drug Administration-mandated postapproval study for a newly approved carotid stent.
October 12, 2004
MQSA reauthorized by U.S. Congress
By AuntMinnie.com staff writers
The House of Representatives passed the Mammography Quality Standards Reauthorization Act of 2004 (H.R. 4555) last week.
October 11, 2004
Stentor gets FDA approval for digital mammo
By AuntMinnie.com staff writers
Image management firm Stentor reported that the Food and Drug Administration has given clearance to the company's iSite PACS for use in the diagnostic reading, enterprise distribution, and archiving of digital mammography images.
October 7, 2004
Final 510(k) decisions for September 2004
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 2004:
October 5, 2004
Cook gets nod for AAA graft
By AuntMinnie.com staff writers
Interventional technology developer Cook has received Food and Drug Administration (FDA) clearance for its Zenith Flex AAA endovascular graft and H&L-B One-Shot introduction system.
October 3, 2004
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