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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."

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.