Haemonetics receives FDA approval for expanded Cymbal use

Haemonetics has been granted approval from the Food and Drug Administration for its automated blood collection device Cymbal to be used on a wider range of donors.

The regulator has ratified the firm’s expanded 510(k) clearance allowing the system to be used on female donors who weight at least 150 lb and are 63 inches tall.

Previously, the portable instrument was only permitted for use among donors who are at least 65 inches in height, with the expanded nomogram now in line with the company’s cleared claim for its MCS+ automated red cell collection system.

Haemonetics stated that this clearance will increase the device’s usefulness in allowing for easier blood collection.

It said: “This approval allows blood collectors to expand utilisation of the Cymbal technology to three to six per cent more female donors, supporting the blood centre’s abilities to optimise donor collections.”

Earlier this month, the company published its financial breakdown for the most recent fiscal quarter, during which it experienced double-digit growth in earnings per share compared to the same period a year earlier.