Regulatory: Page 146

UE LifeSciences gets FDA OK for infrared device
By AuntMinnie.com staff writers
Breast thermography vendor UE LifeSciences has received 510(k) clearance from the U.S. Food and Drug Administration for its NoTouch BreastScan device.
March 5, 2012
CMS solicits imaging accreditation applicants
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a notice in the Federal Register inviting independent accreditation organizations to apply to become a CMS-designated organization for accrediting suppliers furnishing the technical component of advanced diagnostic imaging services.
March 4, 2012
ACR collects over 200 cosponsors for HR 3269
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has amassed 202 bipartisan cosponsors for HR 3269, the Diagnostic Imaging Services Access Protection Act.
March 4, 2012
Health Canada approves Carestream mobile x-ray
By AuntMinnie.com staff writers
Health Canada has issued a medical device license for Carestream Health's DRX-Revolution mobile x-ray system.
February 29, 2012
Varian nets FDA OK for transponder
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for a surface beacon transponder for its Varian Calypso system as a real-time tracking device to monitor motion during radiotherapy for indications anywhere in the body.
February 27, 2012
Koning receives CE Mark for 3D breast CT
By AuntMinnie.com staff writers
Koning has obtained CE Mark approval for its Koning Breast CT system.
February 27, 2012
Eckert & Ziegler gets Chinese approval
By AuntMinnie.com staff writers
Radiotherapy developer Eckert & Ziegler Bebig has received Chinese State Food and Drug Administration clearance for its MultiSource high-dose-rate afterloading system for brachytherapy.
February 27, 2012
IDS nets EHR certification
By AuntMinnie.com staff writers
Integrated Document Solutions (IDS) said that its AbbaDox EHR 8.0 flagship workflow portal has been certified as a complete ambulatory electronic health record (EHR) by a U.S. Office of the National Coordinator Authorized Testing and Certification Body.
February 27, 2012
U-Systems gets FDA meeting for ABUS
By AuntMinnie.com staff writers
Ultrasound developer U-Systems said that its somo.v automated breast ultrasound system (ABUS) will be reviewed by a U.S. Food and Drug Administration advisory panel on April 11.
February 26, 2012
EponaTech gets FDA nod for PACS
By AuntMinnie.com staff writers
Veterinary imaging software developer EponaTech has received U.S. Food and Drug Administration clearance for its Metron-MD radiology PACS software.
February 26, 2012
Cadens nets FDA OK for Colon CT
By AuntMinnie.com staff writers
Cadens Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for its Cadens Colon virtual colonoscopy system.
February 26, 2012
CMS releases stage 2 meaningful use proposed rule -- with imaging
By Kate Madden Yee
In a step that gives clarity to healthcare providers looking to capitalize on federal healthcare IT stimulus funding, the U.S. Centers for Medicare and Medicaid Services (CMS) has published a proposed rule that provides the stage 2 requirements for the government's "meaningful use" program.
February 23, 2012
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