Regulatory: Page 249

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
Kodak DR gets FDA clearance
By AuntMinnie.com staff writers
The Food and Drug Administration has cleared the DirectView DR 7500 digital radiography system from Eastman Kodak Health Group of Rochester, NY.
July 5, 2005
Epix's Vasovist moves closer to market
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals said that the Food and Drug Administration has accepted the firm's May response as a complete response to the FDA's approvable letter for its Vasovist (MS-325) MR blood pool contrast agent.
June 30, 2005
Misonix gets Canadian OK on debrider
By AuntMinnie.com staff writers
Ultrasound developer Misonix has received a Canadian Device License for its ultrasonic wound debridement system.
June 27, 2005
Fluke gets CE Mark
By AuntMinnie.com staff writers
The Radiation Management Services unit of Fluke Biomedical has received the European CE Mark for its Double Check Pro Model 7600, a portable device for therapy beam quality assurance.
June 22, 2005
UltraSPECT gets FDA nod
By AuntMinnie.com staff writers
Israeli nuclear medicine developer UltraSPECT has received Food and Drug Administration 510(k) clearance for its Xpress.cardiac package.
June 15, 2005
Swissray gets FDA OK
By AuntMinnie.com staff writers
Digital radiography developer Swissray International has received Food and Drug Administration 510(k) clearance to market its newest DR system, the ddRCombi Trauma.
June 13, 2005
iCAD nets FDA OK for use with Siemens FFDM
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer iCAD has received Food and Drug Administration 510(k) clearance to package its Second Look Digital system with Siemens Medical Solutions' Mammomat NovationDR full-field digital mammography system.
June 12, 2005
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