In Brief: Selfcare
This article was originally published in The Gray Sheet
Executive Summary
Selfcare: Initial shipments of the firm's electrochemical blood glucose monitoring system to distribution partner Johnson & Johnson's LifeScan subsidiary will be delayed pending an in-house evaluation of the system by J&J, Selfcare announces Sept. 29. Selfcare, which received 510(k) clearance for the system in June, had expected to begin shipments in the third quarter ("The Gray Sheet" July 7, In Brief). Results of the J&J evaluation are due in October. "There can be no assurances that there will not be further delays" in shipments until the results are received, states Selfcare CEO Ron Zwanziger...