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Position Statement on Measurement Based Care

Integrated Care News by CFHA

MBC is presented not simply as data collection, but as a dynamic, evidence-based clinical process that enhances outcomes, promotes equity, and strengthens team-based care. MBC supports optimal clinical practice, demonstrates the value of integrated care teams, and improves outcomes. What is MBC? 3, 4) Why is MBC important? 3, 5, 6) b.

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Electronic Submission Template for Medical Device 510(k) Submissions

FDA Law Blog

The development of an electronic submission template for 510(k) submissions is significant in that: eSTAR submissions are not expected to go through the refuse to accept (RTA) process. eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. (A

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The Future Of Vision And Eye Care

The Medical Futurist

The 80-year-old Ray Flynn lost his central vision entirely, but with the help of the retinal implant, he could make out shapes on the computer screen. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018.

Diabetes 105
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2021 Physician Holiday Gift Guide

Aspiring Minority Doctor

I also love wearing my Medelita Kinetic Scrub Jacket especially since the hospitals and clinics are so cold. This year, I started using the CariPro electronic toothbrush and my mouth definitely feels cleaner. ProCompression Socks Throwback pic from one of my 2018-2019 24hr call shifts I swear by Pro Compression socks!

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Team meetings with subject matter experts can be scheduled to discuss response strategies for deficiencies that require extensive clinical, scientific, or engineering input. 510(k) Time to MDUFA IV Decision.

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Time for Geriatric Assessments in Cancer Care: William Dale, Mazie Tsang, and John Simmons

GeriPal

Based on this surge in evidence, the American Society of Clinical Oncologists recently updated their guidelines for care of older adults to state that all older adults receiving systemic therapy (including chemo, immuno, targeted, hormonal therapy) should receive geriatric assessment guided care. Mazie, welcome to GeriPal. William: Sure.