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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › FDA Provides Second Clearance for Binx MDx Platform

FDA Provides Second Clearance for Binx MDx Platform

Apr 30, 2020
|
staff reporter

NEW YORK – Binx Health said on Thursday it has received a second 510(k) clearance from the US Food and Drug Administration for the Binx io molecular point-of-care platform for the detection of chlamydia and gonorrhea in male urine specimens.

The agency cleared the system in August 2019 for use with clinician and self-collected vaginal swab specimens.

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