BioCentury
ARTICLE | Clinical News

HemaSure regulatory update

July 3, 1995 7:00 AM UTC

HMSR's LeukoNet Pre-Storage Leukoreduction Filtration System was cleared for marketing by the FDA. About 200 licensed blood centers in the U.S. will be targeted by a 4-5 person company sales force. The product has not been priced.

With the U.S. 510(k) approval, HMSR (Marlborough, Mass.), said it intends to file for European approval of the device, with the hope of generating sales by year end. ...