Regulatory: Page 106

Elekta gets FDA clearance for Monaco 5
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Monaco 5 radiation therapy treatment planning systems.
November 26, 2013
CMC lands Orphan Drug Designation by FDA
By AuntMinnie.com staff writers
Swedish contrast media developer CMC Contrast has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its CMC-001 liver-specific contrast agent.
November 26, 2013
IBA secures FDA clearance for imaging software suite
By AuntMinnie.com staff writers
Radiopharmaceutical provider Ion Beam Applications has received U.S. Food and Drug Administration (FDA) clearance for its adaPT Insight imaging software suite.
November 26, 2013
CIVCO's EX3 Stepper gets FDA OK
By AuntMinnie.com staff writers
CIVCO Medical Solutions now can market its EX3 Stepper low-dose-rate and high-dose-rate ultrasound-guided brachytherapy system.
November 20, 2013
FDA warns of risks with Lexiscan, Adenoscan stress agents
By Wayne Forrest
The U.S. Food and Drug Administration on November 20 issued a warning about a "rare but serious risk of heart attack and death" with the use of two cardiac nuclear stress test agents made by pharmaceutical developer Astellas.
November 19, 2013
2013 09 06 11 46 32 375 Fda Logo 200
House subcommittee mulls new approach to mobile app regulation
By Erik L. Ridley
The debate over how best to regulate mobile medical apps reached the halls of the U.S. Congress this week as representatives sparred over a proposed bill that could strip the U.S. Food and Drug Administration of its authority to regulate many types of app software.
November 19, 2013
2009 03 25 14 14 33 939 Capitol Hill 70
USPSTF to review breast screening guidelines
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has begun a review of its guidelines on breast cancer screening -- perhaps opening up a replay of its controversial 2009 decision rescinding support for screening younger women.
November 13, 2013
Patient groups support access to imaging
By AuntMinnie.com staff writers
Thirteen patient groups have submitted a letter urging the U.S. Congress to reject proposals to restrict patient access to medical imaging and radiation therapy technologies.
November 13, 2013
CMS approves RadSite for imaging accreditation
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has approved RadSite as the fourth accreditation organization under the Medicare Improvements for Patients and Providers Act.
November 10, 2013
Fuji SonoSite gets FDA nod for US scanner
By AuntMinnie.com staff writers
Fujifilm SonoSite has received U.S. Food and Drug Administration 510(k) clearance for its X-Porte Ultrasound Kiosk scanner.
November 7, 2013
Claron gets Health Canada nod for NilRead
By AuntMinnie.com staff writers
Advanced visualization and analysis firm Claron Technology has received Health Canada diagnostic approval for its NilRead zero-footprint medical image viewer.
November 7, 2013
Bill would restrict FDA app regulation
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration would be prohibited from regulating some types of mobile medical apps under legislation introduced in the U.S. House of Representatives late last month.
November 3, 2013
Previous Page
Page 106 of 302
Next Page