US-based biomedical diagnostics company Aggredyne received 510(k) clearance from the US Food and Drug Administration (FDA) to market its blood platelet aggregometer, the AggreGuide A-100, and its AA (arachidonic acid) assay that is used to test for aspirin’s effect on platelets.
Aggredyne CEO Dr Ed Teitel said, "This FDA clearance is a critical milestone for Aggredyne. Clearance represents a pivotal validation of our technology as we further our vision to become a leader in the diagnostics sector by advancing guided antiplatelet therapy."
Aggredyne president Bob Hux said, "FDA clearance is a high bar that separates the successful companies from the failures in the medical device industry."
The AggreGuide A-100, manufactured at Aggredyne’s ISO 13485 certified US facility, is already CE marked and marketed internationally.
Along with the total array of platelet testing, the company’s research and development team is expanding the technology to encompass the full arena of coagulation testing and beyond. Toward this end, Aggredyne’s fifth patent was recently issued.