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AAFP Represents Members During 2025 Legislative Session

Alabama Academy of Family Physicians

During the session, the Alabama Academy of Family Physicians actively represented the interests of its members on a range of healthcare initiatives. Pharmacy benefits managers would be further required to pass on 100 percent of rebates received from drug manufacturers to the health benefit plans for which they provide services.

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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. In 2015, surgeons in Manchester, UK have performed the first bionic eye implant for an AMD patient using Second Sight’s innovation. Google is not the only one working on A.I.

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We Have an LDT Proposed Rule!

FDA Law Blog

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. which are offered for a wide variety of clinical applications from consumer health testing to cancer screening. This proposed rule is a long-time coming.

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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

FDA Law Blog

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. If the second test is negative, you should test again 48 hours after the second test.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Screening for addressing hearing loss should be an integral part of what we do in geriatrics and palliative care, but it often is either a passing thought or completely ignored. How to screen for hearing loss. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Is that right? Is that right, Nick?

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. We find that this information is noteworthy for manufacturers to consider. For instance, FDA highlights risks associated with everyday activities (e.g., programming, monitoring, maintenance).