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Seventh Sense Biosystems Gets FDA Clearance for At-Home Blood Collection Device

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."

For decades, only healthcare professionals have been allowed to collect blood for testing, the firm noted. Tap is placed on the upper arm and blood collection starts with the press of a button — a process that usually takes between two and three minutes. After blood is collected, the device can be sent to standard labs for wellness testing, 7SBio said.

Bente said that 7SBio aims to make monitoring much easier for both healthcare professionals and patients, without sacrificing the accuracy of standard lab testing. "We believe that Tap will transform blood collection from an inconvenient, stressful, and painful experience to one where users can perform nearly painless blood collection themselves anywhere," he added.

7SBio is funded by aMoon Fund, Flagship Pioneering, Newpath Partners, Polaris Partners, Laboratory Corporation of America, Miraca, and Novartis.