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Regulatory: Page 236
CCHIT grants ambulatory EHR certification for 17 firms
By
AuntMinnie.com staff writers
U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt announced today that the first ambulatory electronic health record (EHR) products have been certified by the Certification Commission for Healthcare Information Technology (CCHIT).
July 17, 2006
Matrox shipping RoHS boards
By
AuntMinnie.com staff writers
Medical display controller board developer Matrox Graphics reported that four of its display controller board series are compliant with the European Parliament and the Council of the European Union directive on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment.
July 17, 2006
Merit nets CE Mark
By
AuntMinnie.com staff writers
Disposable products provider Merit Medical Systems has received the CE Mark to market its Impress catheter in Europe.
July 16, 2006
Fuji CR mammo approval offers new option for breast imaging
By
Kate Madden Yee
Fujifilm Medical Systems USA announced today that the FDA has given final approval to its premarket approval (PMA) application for a full-field digital mammography (FFDM) system based on computed radiography (CR) technology. The approval gives breast imaging facilities a new option for going digital that should prove to be more economical than FFDM systems currently on the market, according to this Technology Review article.
July 10, 2006
Kyron gets Prism clearance
By
AuntMinnie.com staff writers
MRI advanced visualization application developer Kyron Clinical Imaging has received U.S. Food and Drug Administration clearance to market its Prism Acquire and Prism Process brain imaging products in the U.S.
July 10, 2006
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
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