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Regulatory: Page 237
CA bill to ban leasing deals moves forward
By
AuntMinnie.com staff writers
A bill in the California state legislature to ban certain types of physician leasing arrangements has passed out of a key committee.
July 9, 2006
NEMA releases update to DICOM standard
By
AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) of Rosslyn, VA, has released a 16-part update to the Digital Imaging and Communications in Medicine (DICOM) standard.
July 5, 2006
Cook nets FDA nod
By
AuntMinnie.com staff writers
Interventional technology firm Cook has received U.S. Food and Drug Administration clearance to market its Zilver vascular stent for use in treating symptomatic vascular disease of the iliac arteries.
July 5, 2006
Epix files Vasovist appeal with FDA
By
AuntMinnie.com staff writers
Epix Pharmaceuticals of Cambridge, MA, has submitted a formal appeal to the U.S. Food and Drug Administration to approve the company's blood-pool imaging agent Vasovist.
July 3, 2006
NJ lawmakers propose restriction on ultrasound sales
By
AuntMinnie.com staff writers
The New Jersey legislature is planning to consider a bill that would restrict the sale or lease of certain diagnostic ultrasound equipment to licensed medical personnel.
July 2, 2006
Planmed submits PMA for Nuance FFDM
By
AuntMinnie.com staff writers
Planmed of Roselle, IL, has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its Planmed Nuance full-field digital mammography (FFDM) system.
June 29, 2006
ART files with Health Canada
By
AuntMinnie.com staff writers
Canadian optical molecular imaging developer ART Advanced Research Technologies said it has filed a Medical Device License Application with Health Canada to begin the commercialization of its SoftScan breast imaging device.
June 21, 2006
Cordis Cypher Select Plus nets CE Mark
By
AuntMinnie.com staff writers
Johnson & Johnson subsidiary Biologics Delivery Systems Group, Cordis reported that its third-generation drug-eluting stent, the Cypher Select Plus, has received CE Mark approval.
June 21, 2006
Medtronic to bring Endeavor to China
By
AuntMinnie.com staff writers
Interventional technology firm Medtronic has received regulatory approval from the government of the People's Republic of China for its Endeavor drug-eluting coronary stent system.
June 20, 2006
InSightec to bring Exablate to Australia, Taiwan
By
AuntMinnie.com staff writers
Israeli focused-ultrasound developer InSightec has received regulatory approval from the Australian and Taiwanese governments for the commercial distribution of its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
June 20, 2006
Imagin nets regulatory approval
By
AuntMinnie.com staff writers
PET and PET/CT imaging center developer Imagin Molecular said its wholly owned subsidiary Imagin Nuclear Partners (INP) has received regulatory approval to bill Medicare and Medicaid for PET imaging services.
June 18, 2006
St. Jude Medical gets CE Mark
By
AuntMinnie.com staff writers
Medical device manufacturer St. Jude Medical of St. Paul, MN, reported that it has received European CE Mark approval for its QuickOpt timing cycle optimization application.
June 15, 2006
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