Regulatory: Page 223

Israeli PACS firm gains FDA clearance
By AuntMinnie.com staff writers
Israeli PACS developer CDP has received clearance from the U.S. Food and Drug Administration (FDA) for two multispecialty PACS offerings, the company reported.
November 14, 2007
Medstreaming nets FDA nod
By AuntMinnie.com staff writers
Medstreaming of Seattle has received clearance from the U.S. Food and Drug Administration (FDA) to market its Medical Office suite of products.
November 13, 2007
Vote on MQSA oversight of breast biopsy split by specialty
By Marty Graham
Earlier this week, the National Mammography Quality Assurance Advisory Committee advised the U.S. Food and Drug Administration (FDA) to expand the Mammography Quality Standards Act (MQSA) program to cover stereotactic breast biopsy. But the vote was not unanimous, with one group arguing that regulation was necessary, while others called it cumbersome.
November 7, 2007
FDA panel votes for stereotactic breast biopsy in MQSA
By AuntMinnie.com staff writers
The National Mammography Quality Assurance Advisory Committee has advised the U.S. Food and Drug Administration (FDA) to expand the Mammography Quality Standards Act (MQSA) program to cover stereotactic breast biopsy.
November 5, 2007
Vision RT nets FDA OK and several U.S. sales
By AuntMinnie.com staff writers
U.K. radiation therapy developer Vision RT has received 510(k) clearance from the Food and Drug Administration (FDA) to market its GateCT and GateRT devices in the U.S.
October 28, 2007
European Commission delays MRI usage directive
By AuntMinnie.com staff writers
The European Commission has postponed for at least five years the implementation of the EU Physical Agents Directive, which was designed to protect workers from the potentially harmful effects of electromagnetic fields, including those produced by MRI systems.
October 28, 2007
Neusoft taps TUV for FDA help
By AuntMinnie.com staff writers
Neusoft Positron Medical Systems of Shenyang, China, is partnering with global regulatory compliance firm TUV of Newtown, CT, for help with a FDA 510(k) submission for Neusoft's Attrius PET camera.
October 22, 2007
Medtronic nets CE Mark
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received the European CE Mark for its Endeavor Resolute drug-eluting stent.
October 22, 2007
FDA clears SenoRx US breast biopsy device
By AuntMinnie.com staff writers
Breast cancer interventional device firm SenoRx announced that the U.S. Food and Drug Administration (FDA) has cleared its SenoSonix System.
October 18, 2007
NDS gets FDA nod for Axis V
By AuntMinnie.com staff writers
NDS Surgical Imaging has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Axis V display.
October 17, 2007
CMS nets FDA OK for Monaco
By AuntMinnie.com staff writers
Radiation treatment planning firm CMS of St. Louis has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Monaco, its next-generation intensity-modulated radiation therapy (IMRT) planning platform.
October 15, 2007
Definity to carry warning label
By AuntMinnie.com staff writers
At the behest of the U.S. Food and Drug Administration (FDA), Bristol-Myers Squibb Medical Imaging division of North Billerica, MA, will add a warning label to its echocardiography contrast agent Definity.
October 11, 2007
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