Roche Corp.’s Elecsys pTau217 plasma biomarker test, which has been granted US Food and Drug Administration breakthrough device designation and was developed in partnership with Eli Lilly and Company, helps identify the presence or absence of amyloid pathology of Alzheimer’s disease.
Roche Wins FDA Breakthrough Device Designation For Alzheimer’s Test
Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.