Regulatory: Page 239

Medtronic gets nod for Micro-Driver
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received U.S. Food and Drug Administration clearance for its Micro-Driver coronary stent system.
April 30, 2006
Barco gets FDA 510(k) for Voxar 3D Enterprise
By AuntMinnie.com staff writers
AUSTIN, TX - Image display and advanced visualization software developer Barco has received 510(k) clearance from the U.S. Food and Drug Administration for Voxar 3D Enterprise, the client-server version of its flagship 3D technology.
April 27, 2006
GE gets 510(k) for wide-bore CT scanners
By AuntMinnie.com staff writers
GE Healthcare said it has received FDA clearance for a new family of wide-bore, 16-slice CT systems designed for radiation oncology and radiology use.
April 26, 2006
NAS gets FDA 510(k) for low-dose breast brachytherapy
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) has received 510(k) clearance from the U.S. Food and Drug Administration to market a low-dose-rate radiation treatment version of its breast brachytherapy product.
April 25, 2006
Siemens gets FDA nod for Mammomat mobile
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions reported that the U.S. Food and Drug Administration has issued a premarket approval (PMA) supplement to allow marketing of the company's Mammomat Novation full-field digital mammography (FFDM) system for mobile use.
April 24, 2006
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
2006 04 17 15 42 48 706
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
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