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Regulatory: Page 240
GE gets FDA nod on Senographe Essential
By
AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration approval for its new Senographe Essential digital mammography product.
April 19, 2006
Boston Scientific, Abbott receive FTC OK on Guidant
By
AuntMinnie.com staff writers
Interventional device developers Boston Scientific and Abbott Laboratories reported that they have received antitrust clearance from the U.S. Federal Trade Commission (FTC) for their proposed acquisition of Indianapolis-based Guidant.
April 19, 2006
Contrast-enhanced US picture shows signs of brightening
By
Wayne Forrest
Around the world, contrast-enhanced ultrasound is available for a myriad of applications. In the U.S., however, the FDA has limited its use. But U.S. researchers and practitioners, along with the American Institute of Ultrasound in Medicine, are hoping to gain some ground with the FDA by addressing the concerns surrounding contrast-enhanced ultrasound and highlighting its economic benefits, safety advantages, and future potential.
April 17, 2006
BrainLab gets FDA nod for iPlan Flow
By
AuntMinnie.com staff writers
Image-guided surgery firm BrainLab has received U.S. Food and Drug Administration clearance for its iPlan Flow software.
April 16, 2006
DOBI to bring ComfortScan to Russia
By
AuntMinnie.com staff writers
Optical imaging developer DOBI Medical International has received clearance by the Russian Federal Service of Health Care and Social Development Control for the use of its ComfortScan system in connection with the diagnosis of breast cancer.
April 16, 2006
MQSA reauthorization: What to expect and how to prepare
In September 2007, the Mammography Quality Standards Act (MQSA) will be reauthorized, a process that could bring many changes for your facility. Although 2007 may sound like a long way off, your facility should start preparing for reauthorization by tuning in to the discussions and watching for signs of what may come.
April 12, 2006
Boston Scientific, Abbott get EC approval for Guidant deal
By
AuntMinnie.com staff writers
Interventional device developers Boston Scientific and Abbott Laboratories reported that they have received antitrust clearance from the European Commission for their proposed acquisition of Indianapolis-based Guidant.
April 11, 2006
Kodak gets FDA OK on cardiac PACS apps
By
AuntMinnie.com staff writers
Eastman Kodak Health Group has received U.S. Food and Drug Administration clearance for specialized cardiac functions in its CareStream PACS application.
April 10, 2006
Maxant gets 510(k) for MediPort
By
AuntMinnie.com staff writers
X-ray illuminator firm Maxant Technologies of Niles, IL, has received U.S. Food and Drug Administration 510(k) clearance for its MediPort line of digital workstations.
April 6, 2006
Boston Scientific resolves Guidant antitrust issues
By
AuntMinnie.com staff writers
Interventional device developer Boston Scientific said it had signed an agreement containing consent orders from the U.S. Federal Trade Commission that would resolve the agency's antitrust concerns over the proposed acquisition of Guidant.
April 5, 2006
Siemens gets 510(k) for MVision
By
AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its MVision Megavoltage Cone Beam imaging package for radiation therapy applications.
April 3, 2006
Siemens gets clearance for Axiom upgrades
By
AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions of Malvern, PA, has received U.S. Food and Drug Administration 510(k) clearance for a pair of new technologies for its Axiom vascular imaging systems.
March 29, 2006
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