Regulatory: Page 239

New MRI scanners, applications lead to regulatory upgrades
By Eric Barnes
PEBBLE BEACH, CA - As imaging and interventional applications have multiplied and scanners have grown more powerful in recent years, the dangers in the MRI environment have increased as well. To address the safety issues, regulatory bodies are currently updating old MRI safety standards and are developing new ones, according to a presentation at the Society for Medical Innovation and Technology (SMIT) meeting on Friday.
May 14, 2006
NOPR to host conference call
By AuntMinnie.com staff writers
The U.S. National Oncologic PET Registry (NOPR) said that it will hold an informational conference call for registry participants on Monday, May 15, from 1 p.m. to 2 p.m. EDT.
May 11, 2006
GE gets FDA nod for Voluson i
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for its Voluson i 4D compact ultrasound system.
May 10, 2006
Novadaq lands Spy revision 510(k)
By AuntMinnie.com staff writers
Novadaq Technologies of Toronto said it has received 510(k) clearance from the U.S. Food and Drug Administration for a labeling revision of its Spy intraoperative imaging system.
May 8, 2006
U.S. NRC signs off on NAS brachytherapy
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) said that the Advisory Committee on the Medical Uses of Isotopes to the U.S. Nuclear Regulatory Commission (NRC) has completed its review of its low-dose-rate breast brachytherapy treatment.
May 7, 2006
Hologic gets DEXA clearance
By AuntMinnie.com staff writers
Hologic has received U.S. Food and Drug Administration clearance to market the use of its Discovery dual-energy x-ray absorptiometry (DEXA) system for cardiovascular applications.
May 4, 2006
IDev gets CE Mark for stent
By AuntMinnie.com staff writers
Peripheral vascular disease treatment developer IDev has received the CE Mark for its nitinol stent in Europe.
May 3, 2006
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
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