Regulatory: Page 217

FDA clears Xoft's new applicators
By AuntMinnie.com staff writers
Brachytherapy device developer Xoft of Sunnyvale, CA, has received clearance from the U.S. Food and Drug Administration for applicators to be used with its Axxent electronic brachytherapy system for the treatment of endometrial cancer.
May 20, 2008
Boston Scientific wins FDA clearance for heart failure lead
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration (FDA) for its Acuity Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, the Natick, MA-based company said.
May 18, 2008
FDA clears Fuji's portable digital x-ray unit
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received clearance from the U.S. Food and Drug Administration (FDA) for its portable digital x-ray system, the company reported.
May 14, 2008
Lantheus updates Definity label
By AuntMinnie.com staff writers
Lantheus Medical Imaging of North Billerica, MA, has announced changes to the U.S. product label for Definity Vial For (perflutren lipid microsphere) Injectable Suspension to modify Definity's benefit/risk assessment.
May 12, 2008
PETNet gets U.K. FDG license
By AuntMinnie.com staff writers
Siemens Healthcare said that its PETNet Solutions division has received a full Marketing Authorization and Manufacturer's/Importer's (MIA) license to produce and distribute its FDG biomarker from its Nottingham City Hospital site.
May 11, 2008
FDA clears Covidien RFID contrast system
By AuntMinnie.com staff writers
Covidien has received clearance from the U.S. Food and Drug Administration (FDA) for its contrast delivery system with radiofrequency identification (RFID) technology, the company said.
May 7, 2008
NPI deadline approaching, CMS cautions
By AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) is warning healthcare providers that they must obtain a National Provider Identifier (NPI) by May 23, 2008. After this date, providers can no longer use their old identifier when submitting electronic or paper claims to CMS.
May 7, 2008
Eigen nets clearance for Artemis
By AuntMinnie.com staff writers
Medical imaging developer Eigen has received U.S. Food and Drug Administration (FDA) clearance for its ei-Nav/Artemis prostate cancer imaging device.
May 6, 2008
ACR update: Teaching Congress how to fish
By Kate Madden Yee
LAS VEGAS - At this week's Radiology Business Management Association (RBMA) meeting, Maurine Spillman-Dennis and Ted Burnes presented the American College of Radiology's (ACR) efforts to educate Capitol Hill about radiology, and, in so doing, slow the budget-slashing experiences that radiology has suffered over the past three years.
May 6, 2008
Dilon nets CE Mark
By AuntMinnie.com staff writers
Scintimammography developer Dilon Technologies has received the European CE Mark for its Dilon 6800 gamma camera.
May 5, 2008
GE wins FDA nod to resume C-arm shipments
By Brian Casey
Multimodality vendor GE Healthcare of Chalfont St. Giles, U.K., has received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin manufacturing and distributing surgical mini C-arm shipments from its GE Healthcare Surgery subsidiary. Pete McCabe, president and CEO of the division, explains the steps the company took as part of its consent decree with the FDA.
May 1, 2008
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FDA clears InfraReDx's LipiScan
By AuntMinnie.com staff writers
Coronary imaging developer InfraReDx of Burlington, MA, has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its LipiScan NIR (near-infrared) catheter imaging system.
April 29, 2008
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