Regulatory: Page 216

GE wins FDA nod to resume C-arm shipments
By Brian Casey
Multimodality vendor GE Healthcare of Chalfont St. Giles, U.K., has received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin manufacturing and distributing surgical mini C-arm shipments from its GE Healthcare Surgery subsidiary. Pete McCabe, president and CEO of the division, explains the steps the company took as part of its consent decree with the FDA.
May 1, 2008
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FDA clears InfraReDx's LipiScan
By AuntMinnie.com staff writers
Coronary imaging developer InfraReDx of Burlington, MA, has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its LipiScan NIR (near-infrared) catheter imaging system.
April 29, 2008
Acusphere submits NDA for Imagify
By AuntMinnie.com staff writers
Ultrasound contrast developer Acusphere has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its Imagify ultrasound contrast agent.
April 28, 2008
Epix to resubmit NDA for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals of Lexington, MA, is reporting its results from a blinded, independent reread of images of its blood-pool MRI contrast agent, Vasovist (gadofosveset trisodium).
April 23, 2008
Grable returns to IDSI
By AuntMinnie.com staff writers
Linda B. Grable, co-founder of Imaging Diagnostic Systems (IDSI), has come out of retirement to again become chairman and CEO of the Plantation, FL, company.
April 23, 2008
Medipattern to bring B-CAD to China
By AuntMinnie.com staff writers
Computer-aided detection (CAD) firm Medipattern has received State Food and Drug Administration (SFDA) clearance to market its B-CAD offering in China.
April 21, 2008
CMS applies for 510(k) for RTP software
By AuntMinnie.com staff writers
Radiation treatment planning firm CMS of St. Louis has applied to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of its CMS Atlas-Based Autosegmentation software.
April 20, 2008
Xoran gets FDA warning letter
By AuntMinnie.com staff writers
Specialty CT manufacturer Xoran Technologiesof Ann Arbor, MI, has received a warning letter from the U.S. Food and Drug Administration (FDA) for documentation issues related to its MiniCAT scanner, a compact CT unit used for imaging the sinuses, skull base, and temporal bones.
April 17, 2008
Angiotech gets clearance for central venous catheter
By AuntMinnie.com staff writers
Medical device firm Angiotech of Vancouver, British Columbia, has received clearance from the U.S. Food and Drug Administration for its 5-fluorouracil-coated (5-FU) central venous catheter, the company reported.
April 16, 2008
Boston Scientific earns Canadian approval for Taxus
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received approval in Canada for its paclitaxel-eluting coronary stent system, the Natick, MA-based company said.
April 16, 2008
Neoprobe gets OK for Lymphoseek study
By AuntMinnie.com staff writers
Gamma camera probe developer Neoprobe has received U.S. Food and Drug Administration clearance to launch a phase III multicenter clinical study of its Lymphoseek radiopharmaceutical agent.
April 15, 2008
Candelis gets FDA nod
By AuntMinnie.com staff writers
Archive developer and medical informatics company Candelis has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ImageGrid Mammography Web Viewer and its ImageGrid Radiology Web Viewer.
April 14, 2008
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