Regulatory: Page 222

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
Medtronic's Endeavor moves closer to clearance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has recommended for clearance Medtronic's Endeavor drug-eluting stent for treatment of coronary artery disease, the company reported.
October 10, 2007
FDA clears Pinyons contrast injector
By AuntMinnie.com staff writers
Contrast injector developer Pinyons Medical Technology of Park City, UT, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PowrSyringe injector.
October 10, 2007
Biospace med nets FDA OK on x-ray imager
By AuntMinnie.com staff writers
French digital radiography developer Biospace Med of Paris has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EOS digital x-ray imager for 2D imaging use.
October 8, 2007
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