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.
Cytomedix Inc.
Mako Surgical names new regulatory VP | Personnel Moves
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 begins PMA process for 3D breast scanner | Regulatory Roundup
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 losses more than triple | Earnings roundup
MassDevice keeps a close eye on public medical device companies, tracking their quarterly sales and earnings reports. For the most recent filings, check out our Earnings Roundup, where we collect each quarter’s reports.
Here’s a quick rundown of a few releases over the past couple days:
N.Y. Gov. taps Welch Allyn CEO for state development corp. | Personnel moves
Here’s the latest personnel changes from medical device, diagnostics and life science companies around the nation. For more recent hirings and firings, check out MassDevice’s compilation of the latest personnel moves.
