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AAFP Represents Members During 2025 Legislative Session

Alabama Academy of Family Physicians

Ed Oliver, HB 45 would require the Alabama Medicaid Agency to cover any noninvasive colorectal cancer screening test assigned a grade A or B under the recommendations of the United States Preventive Services Task Force. HB 45 – Medicaid Coverage for Cologuard Test What’s in the Bill: Sponsored by Rep.

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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. Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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We Have an LDT Proposed Rule!

FDA Law

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. The proposed rule has a 60-day comment period for stakeholders.

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

FDA Law

Baumhardt, Senior Medical Device Regulation Expert & Richard A. 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.

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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