Haemonetics has reported that FDA has granted 510(k) for its expanded nomogram to collect two red blood cells on the Cymbal automated blood collection system from female donors who are at least 150 pounds and are 63 inches in height.
Haemonetics’ Cymbal is a small, portable, battery operated instrument that automates blood collection from volunteer donors, improving process control and helping alleviate blood shortages.
The expanded nomogram is identical to the FDA cleared claim for Haemonetics’ MCS+ automated system to collect red cells. Prior to this new approval, donors utilizing the Cymbal technology had to be 150 pounds and 65 inches. This approval allows blood collectors to expand utilization of the Cymbal technology to 3-6% more female donors supporting the blood center’s abilities to optimise donor collections.
Haemonetics is a healthcare company that provides blood management solutions. Together, devices and consumables, information technology platforms, and consulting services deliver a suite of business solutions to help customers improve clinical outcomes and reduce the cost of healthcare for blood collectors, hospitals, and patients around the world. The technologies address important medical markets with blood and plasma component collection, the surgical suite, and hospital transfusion services.