Regulatory: Page 33

Biospace med nets FDA OK on x-ray imager
By AuntMinnieEurope.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
Medtronic launches CareLink in Europe
By AuntMinnieEurope.com staff writers
Interventional technology firm Medtronic has received CE Mark approval for its CareLink Network with Conexus Wireless Telemetry, and the company plans to debut the device in the European Union.
August 29, 2007
FDA clears GE FFDM unit for mobile use
By AuntMinnieEurope.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has received U.S. Food and Drug Administration (FDA) clearance to market its Senographe Essential full-field digital mammography (FFDM) system for mobile use.
August 21, 2007
Alliance for MRI gains delay, but new European rules still loom
By Brenda Tilke
A coalition of European MRI advocates won a partial victory in June in its fight against new safety regulations that some believe will effectively shut down the use of MRI across the European Union. But the Alliance for MRI, led by the European Society of Radiology (ESR) of Vienna, faces additional struggle in winning a permanent injunction against implementation of the rules.
July 25, 2007
DraxImage files for European clearance
By AuntMinnieEurope.com staff writers
Canadian radiopharmaceutical firm DraxImage has filed an application for its sestamibi kit with European regulatory authorities.
July 24, 2007
Median gets 510(k) for lung and liver apps
By AuntMinnieEurope.com staff writers
French computer-aided detection (CAD) developer Median Technologies has received 510(k) clearance from the U.S. Food and Drug Administration for its LMS-Lung/Track and LMS-Liver applications.
June 17, 2007
Viatronix, Medicsight net CE Mark
By AuntMinnieEurope.com staff writers
Advanced visualization firm Viatronix and computer-aided detection (CAD) partner Medicsight of London have jointly released their integrated virtual colonoscopy CAD offering in Europe.
June 12, 2007
InSightec nabs CE Mark
By AuntMinnieEurope.com staff writers
Focused-ultrasound developer InSightec announced that its ExAblate 2000 system has received the European CE Mark certification for pain palliation of bone metastases.
June 6, 2007
European radiology mobilizes to stave off MRI safety rules
By Brian Casey
VIENNA - A number of European academic societies, including the European Society of Radiology (ESR), have formed a coalition to try to prevent the adoption of safety rules set to go into effect in 2008 that could severely limit the types of MRI studies that can be conducted in the European Union. Called the Alliance for MRI, the coalition was launched here today at the European Congress of Radiology (ECR).
March 8, 2007
ART lands CE Mark
By AuntMinnieEurope.com staff writers
Canadian optical molecular imaging developer ART Advanced Research Technologies has received the European CE Mark for its SoftScan optical breast imaging device.
February 7, 2007
Advanced Magnetics, Guerbet file for European clearance of Combidex
By AuntMinnieEurope.com staff writers
MRI contrast developer Advanced Magnetics said that its European partner Guerbet has filed a marketing authorization application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for its Combidex functional MRI agent.
December 5, 2006
NeuroLogica nets CE Mark
By AuntMinnieEurope.com staff writers
Mobile CT developer NeuroLogica has received the European CE Mark for its CereTom portable CT scanner.
October 8, 2006
Previous Page
Page 33 of 34
Next Page