Regulatory: Page 263

Siemens gets FDA mobile C-arm OK
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received marketing clearance from the Food and Drug Administration for its Axiom Artis U, a moveable digital C-arm system.
July 21, 2004
Boston Scientific gets FDA nod for Liberte clinical trial
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has received an investigational device exemption from the Food and Drug Administration to begin its ATLAS clinical trial using its Liberte coronary stent as a platform for the firm's paclitaxel-eluting coronary stent system.
July 21, 2004
Stark II interim final rule leaves huge self-referral loophole
By Cherrill Farnsworth
The National Coalition for Quality Diagnostic Imaging Services welcomes the additional flexibility that the U.S. Centers for Medicare and Medicaid Services has brought to the Stark Laws. However, a substantial loophole remains in the statute with regard to the in-office ancillary services exception, according to an editorial by Cherrill Farnsworth.
July 19, 2004
Totoku gets added FDA clearance
By AuntMinnie.com staff writers
Display manufacturer Totoku Electric has received additional Food and Drug Administration 510(k) clearance for its ME511L flat-panel display.
July 18, 2004
ProSolv gets CE Mark
By AuntMinnie.com staff writers
Cardiology digital imaging and reporting software developer Problem Solving Concepts (ProSolv) of Indianapolis said that it has received the European Union's CE Mark for its ProSolv Cardiovascular product.
July 14, 2004
Agfa PACS, RIS gateway get Air Force OK
By AuntMinnie.com staff writers
Agfa HealthCare of Greenville, SC, reported that its Impax PACS product has received the Approval to Operate (ATO) and a Certificate of Networthiness (CoN) from the U.S. Air Force Surgeon General's office and the Air Force Communications Agency.
July 14, 2004
Longport gets CE Mark
By AuntMinnie.com staff writers
Ultrasound developer Longport has received the CE Mark for its EpiScan I-200 ultrasound imaging system.
July 12, 2004
R2 gets FDA nod for lung-nodule CAD
By AuntMinnie.com staff writers
Computer-aided detection developer R2 Technology has received Food and Drug Administration clearance for its ImageChecker CT CAD software. ImageChecker CT was cleared for the detection of solid lung nodules during review of multidetector CT (MDCT) chest exams, according to the Sunnyvale, CA-based vendor.
July 11, 2004
ONI gets CE Mark
By AuntMinnie.com staff writers
Extremity MRI developer ONI Medical Systems reported that its OrthOne 1-tesla extremity MRI system has received CE Mark approval.
July 8, 2004
Epix launches new MS-325 trial
By AuntMinnie.com staff writers
MR contrast developer Epix Medical has launched a multicenter trial evaluating its MS-325 blood pool contrast agent for high-resolution vessel imaging.
July 7, 2004
FDA proposes globally harmonized premarket review
The Food and Drug Administration (FDA) has proposed the implementation of a voluntary pilot premarket review program aimed at reducing the burden on manufacturers who face conflicting premarket submission format and content requirements in different countries. The proposed pilot program will evaluate the utility of an alternative procedure for device premarket submissions.
July 7, 2004
Final 510(k) decisions for June 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for June 2004:
July 6, 2004
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