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The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices

C&M Health Law

Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). If this latest draft guidance is finalized after a period of public comment, the agency will incorporate the proposed language into the 2018 guidance.

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How Will New FDA Hearing Aid Regulations Impact Health Plans?

HIT Consultant

First, let’s examine the new regulatory framework the FDA established. Health plans should be on the alert for potential pitfalls arising from the new regulations. Health plans can design hearing benefits that can mitigate this potential issue while maximizing member satisfaction at the same time. Introducing OTC hearing aids.

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Remanufacturing or Servicing of Medical Devices: FDA Issues Final Guidance Providing Additional Clarification

Hall Render

Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). In May 2024, the U.S. Below are some highlights from the Final Guidance.

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Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes.

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Cuffless Blood Pressure Monitoring – Not for the Faint-of-Heart (Pun Intended)

Healthcare IT Today

The excitement has been largely fueled by the renowned public health benefits of, and the seductive commercial opportunity for, a seamless hypertension management solution that is virtually invisible – part of what people are already wearing, such as smartwatches, earbuds, smart rings, and apparel.

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CareCloud CEO predicts what's around the corner for telehealth

Healthcare IT News - Telehealth

What's less certain, however, is what that utilization will look like in the future, particularly as the end of the public health emergency looms. We launched our first fully integrated telehealth solution in the 2018-2019 timeframe. First of all, we should think about the public health emergency.

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HHS-OIG Excludes Theranos Founder and CEO from Federal Health Programs for 90 Years

HIPAA Journal

The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Theranos and Homes denied the allegations and threatened to sue Carreyrou; however, in 2018, Homes stepped down from her position as CEO, and following an FBI investigation the company was shut down.

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