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Regulatory: Page 275
Cochlear implant gets OK for MR use
By
AuntMinnie.com staff writers
MED-EL's Combi 40+ cochlear implant has received Food and Drug Administration approval for use with MRI.
June 18, 2003
IDSI PMA judged suitable for filing
By
AuntMinnie.com staff writers
CT laser mammography developer Imaging Diagnostic Systems has been notified by the Food and Drug Administration that an initial review of its pre-market approval (PMA) application for its CT breast imaging system has been judged to be suitable for filing.
June 17, 2003
Varian gets 510(k) for VariSeed 7.1
By
AuntMinnie.com staff writers
X-ray and radiation therapy developer Varian Medical Systems has received Food and Drug Administration 510(k) marketing clearance for the 7.1 iteration of VariSeed.
June 4, 2003
RITA gets 510(k) for new ablation electrode
By
AuntMinnie.com staff writers
RITA Medical Systems of Mountain View, CA, has received 510(k) clearance from the FDA for the latest addition to its line of radiofrequency ablation electrodes.
May 4, 2003
EP MedSystems gets CE Mark
By
AuntMinnie.com staff writers
Cardiac electrophysiology developer EP MedSystems has received European Notified Body regulatory approval for its ViewMate intracardiac ultrasound catheter system.
May 1, 2003
Imaging Diagnostic Systems files PMA
By
AuntMinnie.com staff writers
Laser breast imaging developer Imaging Diagnostic Systems (IDS) has submitted a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration seeking marketing approval for its computed tomography laser mammography (CTLM) system.
April 29, 2003
U.S. PET backers win some, lose some
By
AuntMinnie.com staff writers
PET proponents got good news and bad on the reimbursement front this week, with the Centers for Medicare and Medicaid Services (CMS) announcing that it will begin Medicare reimbursement coverage for some new indications, but that others aren't ready for prime time.
April 16, 2003
CMS sets date for expanded MRA coverage
By
AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) said Wednesday that its expansion of coverage for new MR angiography applications will go into effect on July 1.
April 16, 2003
Aloka launches new OB ultrasound scanner
By
AuntMinnie.com staff writers
Ultrasound vendor Aloka has received Food and Drug Administration clearance to begin marketing SSD-3500, a digital scanner targeted at ob/gyn and perinatology applications.
April 15, 2003
U.S. to expand MRA coverage
By
AuntMinnie.com staff writers
An expansion in insurance reimbursement is in the works for MR angiography of the abdomen and pelvis, according to a decision memo issued Tuesday by the Centers for Medicare and Medicaid Services (CMS).
April 15, 2003
PointDx receives 510(k) clearance
By
AuntMinnie.com staff writers
Structured-reporting developer PointDx has received Food and Drug Administration 510(k) marketing clearance for the firm’s REX workstation 3.0.
April 8, 2003
Siemens files PMA for FFDM system
By
AuntMinnie.com staff writers
Siemens Medical Solutions of Malvern, PA, has filed a premarket approval (PMA) application with the Food and Drug Administration for its first full-field digital mammography system, Mammomat NovationDR.
April 6, 2003
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