Regulatory: Page 33

BioSphere nets CE Mark OK
By AuntMinnieEurope.com staff writers
Interventional device developer BioSphere Medical has received the European CE Mark for transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using its HepaSphere microspheres.
December 17, 2007
FDA OKs Compass dosimetry device
By AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Stockholm-based RaySearch Laboratories and Ion Beam Applications (IBA) of Louvain-la-Neuve, Belgium, for their jointly developed Compass dosimetry device.
December 17, 2007
Vision RT nets FDA OK and several U.S. sales
By AuntMinnieEurope.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 AuntMinnieEurope.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
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
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