Alliance’s expanding portfolio
This article was originally published in The Gray Sheet
Executive Summary
Simulated clinical use studies showing substantial equivalence of reprocessed compression sleeves to new devices were conducted in support of 510(k)s cleared by FDA, Phoenix-based reprocessor reports March 17. Approval of three compression sleeves and an external fixation devices follows the recent market clearance of tissue stabilizers, heart positioners and chest retractors, bringing Alliance Medical's total number of 510(k) clearances to 26...