Regulatory: Page 249

Siemens gets FDA OK for Avantic
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for Arcadis Avantic, a mobile C-arm system.
August 14, 2005
CMS sets final date for HIPAA TCS compliance
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will not process incoming non-HIPAA-compliant electronic Medicare claims submitted for payment beginning October 1 this year.
August 4, 2005
Medstrat gets FDA nod
By AuntMinnie.com staff writers
Orthopedic imaging informatics developer Medstrat has received Food and Drug Administration 510(k) clearance for its echoeSystem orthopedic PACS software.
August 3, 2005
Intuitive Imaging gets FDA nod
By AuntMinnie.com staff writers
PACS firm Intuitive Imaging Informatics has received Food and Drug Administration 510(k) clearance for its ImageQube PACS network.
August 1, 2005
Suros gets Canadian approval for ATEC
By AuntMinnie.com staff writers
Interventional technology developer Suros Surgical Systems said it has received clearance from the Canadian government to sell its Automated Tissue Excision and Collection (ATEC) system for breast biopsy and excision in that country.
July 26, 2005
ACR questions proposed Medicare imaging pay cuts
By Tracie L. Thompson
The American College of Radiology is planning to "express its concerns" about a proposal by the U.S. Centers for Medicare and Medicaid Services (CMS) to reduce technical component payments for multiple imaging services on contiguous body parts.
July 26, 2005
BSD gets favorable patent notice
By AuntMinnie.com staff writers
Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City has received an official notice of allowance for a new patent expected to be issued by the U.S. Patent Office.
July 25, 2005
FDA rejects Biofield data
By AuntMinnie.com staff writers
The Food and Drug Administration has asked breast technology developer Biofield to conduct more clinical testing in support of a regulatory submission for its Breast Cancer Detection System.
July 24, 2005
CMS proposes cuts for 'add-on' imaging studies
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has proposed paying a reduced rate for additional imaging procedures that are performed after an initial imaging study is done.
July 18, 2005
ArthroCare receives FDA clearance
By AuntMinnie.com staff writers
Medical device firm ArthroCare of Sunnyvale, CA, received notice from the Food and Drug Administration that its Parallax Acrylic Resin with Tracers-Ta Bone Cement Opacifier has been cleared for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures.
July 14, 2005
New draft of MQSA up for public review
By AuntMinnie.com staff writers
The Food and Drug Administration (FDA) has released a draft of its modifications and additions to the Mammography Quality Standards Act (MQSA). Comments on this latest version must be submitted within 90 days of July 15 to the Center for Devices and Radiological Health (CDRH).
July 14, 2005
NAS nets 510(k)
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) reported that its Nomos radiation oncology division has received 510(k) clearance from the Food and Drug Administration to market nTRAK, a new stereotactic image guidance system used to position and monitor patients during radiation therapy treatments for head and neck cancers.
July 7, 2005
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