US clearance for PharmaNetics' heparin test panel:
This article was originally published in Clinica
Executive Summary
PharmaNetics has received US FDA 510(k) clearance for its Heparin Management Panel and Accent system, which adds two new test cards, the Heparin Titration Test and the Protamine Response Test, as well as new hardware to the company's current Heparin Management Test, which runs on its Thrombolytic Assessment System (TAS). The Accent hardware automatically calculates information to manage anticoagulation in patients during cardiopulmonary bypass procedures. Bayer Diagnostics, which markets TAS as Rapidpoint Coag, will market the new product as Rapidpoint ACCENT. Raleigh, North Carolina-based PharmaNetics is the holding company of Cardiovascular Diagnostics.