Regulatory: Page 119

FDA clears new use for GE's AdreView SPECT tracer
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has approved a new cardiac indication for the AdreView (iobenguane I-123 injection) SPECT radiopharmaceutical from GE Healthcare.
March 21, 2013
Piramal's florbetaben PET agent to be reviewed
By AuntMinnie.com staff writers
Piramal Imaging said that the U.S. Food and Drug Administration and the European Medicines Agency have accepted the company's applications for review of its florbetaben investigational PET amyloid imaging agent.
March 20, 2013
House makes progress on helium supply bill
By AuntMinnie.com staff writers
Legislation that would stabilize the U.S. supply of helium, used to cool MRI magnets, took a step forward this week with the advancement of a bill in the U.S. House of Representatives.
March 20, 2013
FDA clears iCAD's cervical applicator for Xoft Axxent
By AuntMinnie.com staff writers
Computer-aided detection and radiation therapy firm iCAD has received clearance from the U.S. Food and Drug Administration for its new cervical applicator for use with the Xoft Axxent electronic brachytherapy system.
March 20, 2013
FDA approves Guerbet's Dotarem MRI contrast
By AuntMinnie.com staff writers
French contrast developer Guerbet has received approval for its Dotarem (gadoterate meglumine) MRI contrast agent from the U.S. Food and Drug Administration.
March 19, 2013
EOS gets FDA nod for 3D x-ray software
By AuntMinnie.com staff writers
Orthopedic digital imaging firm EOS Imaging has received U.S. Food and Drug Administration 510(k) clearance for version 1.5 of its sterEOS 3D imaging software.
March 18, 2013
Faxitron gets OK to sell in Brazil
By AuntMinnie.com staff writers
Faxitron said it has received approval from the Brazilian National Health Surveillance Agency to sell its digital specimen radiography systems in Brazil.
March 17, 2013
RA bill introduced into U.S. House
By AuntMinnie.com staff writers
Federal legislation that would establish Medicare recognition of radiologist assistants (RAs) as nonphysician healthcare services providers has been introduced in the U.S. House of Representatives.
March 17, 2013
MedPAC: Imaging volume drops, but long-term growth is high
By Kate Madden Yee
Imaging volume per Medicare beneficiary fell by 1% from 2010 to 2011, but the decline represents just a small part of the overall rapid growth of imaging procedures over the past decade, according to the Medicare Payment Advisory Commission's (MedPAC) annual report to Congress.
March 14, 2013
CMS to loosen strings on oncology PET payments
By Brian Casey
In a move that should make PET reimbursement easier for most oncology applications, the U.S. Centers for Medicare and Medicaid Services (CMS) this week proposed removing its longstanding requirement that FDG-PET scans of patients with solid tumors be reported to a national data registry.
March 13, 2013
ONC chief Mostashari believes data can fix U.S. healthcare
By Cynthia E. Keen
Intelligent use of data can fix a broken healthcare system, said Dr. Farzad Mostashari, national coordinator for health IT within the U.S. Office of the National Coordinator (ONC). Mostashari delivered the final keynote address of the Healthcare Information and Management Systems Society meeting last week in New Orleans.
March 13, 2013
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FDA clears Navidea's Lymphoseek
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration announced it has cleared radiopharmaceutical developer Navidea Biopharmaceuticals' Lymphoseek diagnostic imaging agent.
March 12, 2013
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