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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The third article—“Your Medical Devices are Getting Smarter. The first article—“Is the Eye the Window to Alzheimer’s?”—discusses demographic bias of data fed to algorithms).

Medical 119
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A podcast on the evaluation and management of penetrating neck injuries in children

PEMBlog

Evaluate clinical findings to determine the need for operative intervention versus observation in stable pediatric patients with soft versus hard signs of vascular or aerodigestive injury. Now, you may recall some teaching that you got in medical school or residency where the management was dictated by which zone was injured.

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Orthopedic Pain Management: When to Skip the Specialist

Priority Physicians

But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release. The government asserted additional allegations that are outside our scope.

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Two “Unresolvable” Prescribing/Dispensing Red Flags Unfurled

FDA Law

Houck We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.

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Advanced Imaging of Children in the ED: Ultrasound, CT, and MRI

PEMBlog

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

Families 101
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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J. 21 U.S.C. §

Clinic 59