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9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells. Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth.

Patients 126
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Episode 354: Antiracism in Medicine – Episode 25 – Live from SGIM 2024: Best of Antiracism Research at the Society of General Internal Medicine’s 2024 Annual Meeting

The Clinical Problem Solvers

Michelle Ogunwole, MD, PhD is a health disparities researcher, social epidemiologist and General Internal Medicine physician specializing in the care of women with chronic medical conditions. During this episode, we hear from Dr. S. She has advanced training in Quality Improvement and Patient Safety Science. References Ogunwole, S.

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Episode 262: Anti-Racism in Medicine Series – Episode 18 – Remedying Health Inequities Driven by the Carceral System

The Clinical Problem Solvers

Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration. The ways to remedy the negative impacts of incarceration are to incarcerate fewer people and to invest in communities.

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A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases

FDA Law Blog

These remarks by Dr. Dunn and his Summary Review offer insights into the practical application of the FDA’s December 2019 draft guidance on substantial evidence of effectiveness (as we will discuss further below). By Frank J. Sasinowski & James E. Hyman, Phelps & McNamara, P.C.’s

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Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law Blog

As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.

Medical 59
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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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PETA Petition to FSIS to Remove Animal Raising Claims from Label Approval Process

FDA Law Blog

On the other hand, labels that bear so-called “special statements and claims” must be submitted to and approved by FSIS’s Labeling Program and Delivery Staff before they can be used on meat or poultry products. The list of special statements and claims, in FSIS regulation 9 CFR 412.1 (e), e), includes so called “animal raising claims.”