Category: Cytomedix Inc.
The Centers for Medicare & Medicaid Services hammers out a reimbursement plan for plasma systems including Cytomedix's AutoloGel wound-healing technology.
Cytomedix (OTC:CMXI) touted a reimbursement win from the Centers for Medicare & Medicaid Services for plasma systems including its AutoloGel product.
The coverage decision includes Cytomedix's platelet-rich plasma system for patients with chronic ulcers and wounds, under the Coverage with Evidence Development program, a CMS guidance policy that gathers data and public comments to include in coverage decisions.
Riding high on a record-setting 4th quarter, Cytomedix announces $27.5 million in financing for 2013, a move that precedes a 20% slide on Wall Street.
Regenerative therapies maker Cytomedix (OTC:CMXI) plans to raise up to $27.5 million through a "comprehensive 2013 financing plan" in order to maintain the momentum that led to record sales in the last quarter.
Cytomedix lands CE Mark approval in the European Union for its Angel concentrated platelet rich plasma system, which received FDA clearance last month.
Cytomedix (OTC:CMXI) received the CE Mark approval in the European Union for its Angel concentrated platelet rich plasma system.
The FDA clears Cytomedix's Angel concentrated platelet rich plasma system, an advanced autologous whole blood and bone marrow separation technology, with which the company hopes to expand its orthopedic footprint.
Cytomedix (OTC:CMXI) received FDA clearance for its Angel concentrated platelet rich plasma system, a whole blood separation system designed to produce consistently high platelet yields.
Mako Surgical names Lawrence Gibbons to replace the retiring James Keller as its vice president of regulatory affairs.
Mako Surgical (NSDQ:MAKO) tapped Lawrence Gibbons to replace its regulatory affairs vice president, James Keller, who resigned effective Feb. 3.
Gibbons, 60, was most recently with Fisher & Paykel Healthcare (NZE:FPH), where he helped establish a manufacturing facility in Mexico and set up the quality system at the company’s New Zealand headquarters.
GE Healthcare files the first module of a pre-market approval application for its Senographe Essential breast tomosynthesis device ; also, Maquet wins 510(k), CE Mark for CardioSave IABP; J&J's Ethicon Endo-Surgery gets 510(k) nod for Enseal G2 tissue sealers; and Cordis lands clearances for Empira dilation catheters.
GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.
The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.
Kips Bay Medical Inc.'s losses more than triple in the first year the company begins selling its product.
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Here's a quick rundown of a few releases over the past couple days: