Regulatory: Page 143

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
ACR, MITA call for Medicare coverage of VC
By AuntMinnie.com staff writers
The American College of Radiology (ACR) and the Medical Imaging and Technology Alliance (MITA) are calling for Medicare coverage of virtual colonoscopy, according to statements from the two organizations.
February 22, 2012
HIMSS: Imaging included in stage 2 of meaningful use
By Erik L. Ridley
LAS VEGAS - Viewing of images will be included in the proposed stage 2 requirements for achieving meaningful use under the U.S. government's healthcare IT stimulus program, according to an announcement on Wednesday at the Healthcare Information and Management Systems Society (HIMSS) meeting.
February 21, 2012
FDA to fast track Repligen's SecreFlo
By AuntMinnie.com staff writers
Repligen announced that the U.S. Food and Drug Administration will give priority review to the company's new drug application (NDA) for SecreFlo in combination with MRI to improve the detection of pancreatic duct abnormalities in patients with pancreatitis.
February 20, 2012
Nucletron gets Japanese brachytherapy approval
By AuntMinnie.com staff writers
Brachytherapy firm Nucletron has received Shonin approval from the Japanese Ministry of Health, Labor, and Welfare to sell its microSelectron Digital brachytherapy afterloader in Japan.
February 20, 2012
Elekta gets FDA OK for ultrasound option
By AuntMinnie.com staff writers
Oncology firm Elekta has received 510(k) clearance from the U.S. Food and Drug Administration for an autoscan option that allows remote, automated ultrasound scanning with Elekta's Clarity soft-tissue visualization system.
February 20, 2012
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