Regulatory: Page 264

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
NeoRx files IND for radiotherapy agent
By AuntMinnie.com staff writers
Radiotherapy pharmaceutical developer NeoRx has filed an investigational new drug (IND) application with the Food and Drug Administration for a phase II clinical study of its Skeletal Targeted Radiotherapy (STR) product in patients with breast cancer that has metastasized to the bone, according to the Seattle-based vendor.
July 5, 2004
Mallinckrodt, Palatin get FDA approval
By AuntMinnie.com staff writers
Contrast agent developer Palatin Technologies of Cranbury, NJ, and corporate partner Mallinckrodt have received approval from the Food and Drug Administration to market and distribute NeutroSpec.
July 5, 2004
Lodox gets CE Mark for Statscan
By AuntMinnie.com staff writers
Lodox Systems North America of South Lyon, MI, has received the CE Mark for its Statscan Critical Imaging System.
June 30, 2004
Radiology group pays $2.5 million to settle alleged Medicare fraud
By Tracie L. Thompson
A radiology group in southwest Florida has agreed to pay the U.S. government more than $2.53 million to settle allegations that it filed false Medicare claims -- allegations first lodged in a whistleblower lawsuit by the practice's former Medicare coding supervisor.
June 28, 2004
Planar gets 510(k) for flat-panel mammo display
By AuntMinnie.com staff writers
Monitor manufacturer Planar Systems has received 510(k) clearance from the Food and Drug Administration for a 5-megapixel flat-panel display designed for use with full-field digital mammography (FFDM) systems.
June 22, 2004
Previous Page
Page 264 of 303
Next Page