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Remote Patient Testing Faces a Cloudy Future under VALID

FDA Law Blog

Laboratories also routinely supply third-party sourced collection devices from IVD manufacturers and distribute them to end users, which may include blood collection stations, physician offices, or – increasingly – individuals at home. Many of these collection devices are classified as Class I, 510(k)-exempt (e.g.,

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It’s All So Simple Now: The First Traditional Marketing Authorization for a Non-PCR Based Test to Detect SARS-CoV-2

FDA Law Blog

This device is indicated for the following use: for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset.

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Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

FDA Law Blog

This is particularly true for home collection devices, where CDRH requires more data to demonstrate the ability of a lay user to collect an adequate sample for each individual test. dried blood, in viral transport media). This approach to regulation of collection devices is overly burdensome and it discourages innovation.

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Social Risk Burden and Its Impact on Healthcare Use in IBD

Physician's Weekly

They analyzed data to estimate social risks across 6 domains—food insecurity, financial hardship, housing instability, transportation needs, education and employment, and discrimination—in adults with IBD. A greater social risk burden was linked to increased odds of unplanned healthcare utilization (severe vs none: OR, 3.5 [1.2-10.2])

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Middle to Older Age Latinas Experiences Across the Cervical Cancer Continuum: Screening, Diagnosis, Treatment and Impact [Health care disparities]

Annals of Family Medicine

Methods: In-depth semi-structured interviews using the Database of Individual Patient Experiences (DIPEx) methodology. Participants were recruited via electronic healthcare records, community tabling events, and social media efforts. Verbatim transcripts in English and Spanish were analyzed in NVivo 14.

Diagnosis 130
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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Eric: Oh, no.

Community 114
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Episode 322: Antiracism in Medicine – Episode 24 – Leveraging Narrative Medicine to Cultivate Antiracist Praxis

The Clinical Problem Solvers

She started in the Narrative Medicine program at Columbia around Sayantani, and wanted to focus on incarceration as a healthcare issue, and has since engaged in work that attempts to decarcerate health care. She discovered narrative medicine, and to her, it was about finding and retelling individual and structural stories in antiracist ways.