Instrumentation Laboratory Co. and General Electric Co. (NYSE:GE) subsidiary Vital Signs Devices Inc. are undergoing Class 1 recalls for medical devices.
Premier GPO inks two new deals
Premier Inc. announced two new deals today, bringing them to four contracts this week alone.
The hospital group purchasing organization signed contracts with Deerfield, Ill.-based Siemens AG (NYSE:SI) and Instrumentation Laboratory of Bedford, Mass.
Smiths’ H1 sales rise 7 percent | 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:
Instrumentation Laboratory wins 510(k) clearance for thrombosis assay
Instrumentation Laboratory landed 510(k) clearance from the Food & Drug Administration for its HemosIL D-Dimer HS 500 assay, which the company says can effectively rule out the possibility of thrombosis in patients.
The Bedford, Mass.-based company also announced a deal with Health Canada to license the product north of the border; the assay has been available in Europe for about 10 months. Instrumentation Laboratory said the clearance from regulators marks the beginning of its commercialization of the assay in North America, with the help of its distribution partner Beckman Coulter Inc. (NYSE:BEC).