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How Gut Health and Digestion Influence Cholesterol Levels

Imperial Center Family Medicine

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. To eliminate excess cholesterol, specialized liver enzymes transform it into bile salts that get stored in your gallbladder. LDL and HDL are two famous examples, carrying cargo to and from tissues and blood vessels as needed.

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MN Legislative Session 2025: Updates on Health Care Bills

Minnesota Academy of Family Physicians

The Minnesota Hospital Association, as well as some individual hospitals, testified in support of the bill. The bill addresses Medicare supplement policies and individual health plans , including: Allowing Medicare supplement policies to factor in late enrollment and reenrollment when determining premiums. Read a summary of S.F.

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The Healthcare Vision of ChatGPT-4o and Multimodal LLMs

The Medical Futurist

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

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Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law Blog

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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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

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law Blog

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.