The Food & Drug Administration expanded a 510(k) clearance for a Haemonetics Corp. (NYSE:HAE) device used to collect blood.
The Braintree, Mass.-based firm said the FDA expanded its clearance to use its Cymbal automated blood collection system for female blood donors who weigh at least 150 pounds and are 63 inches in height.
The expanded clearance, which came through Jan. 27, mirrors the clearance the FDA already granted for Haemonetics’ MCS+ automated system to collect red cells, from female donors who weigh 150 pounds and are 65 inches tall. Haemonetics said the new clearance widens the pool of available female donors for the Cymbal system by 3 percent to 6 percent.
