NEW YORK – Medford, Massachusetts-based Seventh Sense Biosystems (7SBio) said Tuesday that the US Food and Drug Administration has given it a 510(k) clearance that is an extension of an existing clearance and enables blood collection by laypersons as well as for wellness testing use at home.
7SBio CEO Rick Bente said in a statement that the clearance of the firm's push-button blood collection device, Tap, "has the potential to significantly improve patient outcomes."