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   Articles with "fda cleared" as a keyword



Evaluation of an investigational wearable injector in healthy human volunteers

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recommendations! Published in 2017 at "Expert Opinion on Drug Delivery"

DOI: 10.1080/17425247.2017.1252748

Abstract: ABSTRACT Objectives: Introduction of a wearable device for subcutaneous delivery of larger volume bolus injections would encourage patient compliance and reduce the burden on healthcare services. With one such wearable device commercially available, this study… read more here.

Keywords: fda cleared; investigational device; control devices; pain ... See more keywords

The impact of FDA-cleared molecular solutions for BK polyomavirus quantitation

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recommendations! Published in 2025 at "Journal of Clinical Microbiology"

DOI: 10.1128/jcm.00348-24

Abstract: ABSTRACT Accurate detection and monitoring of BK polyomavirus (BKV) infection is of critical importance in the post-transplant period, guiding treatment decisions that balance the anti-rejection effects of immune suppression with host-protective effects of immune defense.… read more here.

Keywords: fda; impact fda; molecular solutions; fda cleared ... See more keywords
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P021 Use of non-FDA cleared assays for detection of STIs in children being evaluated for suspected sexual abuse

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recommendations! Published in 2019 at "Sexually Transmitted Infections"

DOI: 10.1136/sextrans-2019-sti.230

Abstract: Background Although NAAT testing is the gold-standard for C. trachomatis (Ct) and GC in adults, limited data exists for children. Although there are now 7 FDA cleared Ct/GC NAATs in the US, assays that are… read more here.

Keywords: suspected sexual; fda cleared; sexual abuse; evaluated suspected ... See more keywords

Performance characteristics of the first Food and Drug Administration (FDA)-cleared digital droplet PCR (ddPCR) assay for BCR::ABL1 monitoring in chronic myelogenous leukemia

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recommendations! Published in 2022 at "PLoS ONE"

DOI: 10.1371/journal.pone.0265278

Abstract: Chronic myelogenous leukemia (CML) is a hematopoietic stem cell malignancy that accounts for 15–20% of all cases of leukemia. CML is caused by a translocation between chromosomes 9 and 22 which creates an abnormal fusion… read more here.

Keywords: myelogenous leukemia; bcr abl1; bcr; performance ... See more keywords