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

FDA Law

—discusses several approaches that companies are exploring for use of AI in the diagnosis of Alzheimer’s Disease, including AI-enabled software for retinal scans and identification of genetic triggers. In the second article—“Why AI is Medicine’s Biggest Moment Since Antibiotics”—Dr. demographic bias of data fed to algorithms).

Medical 119
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AMPLIFY™ Technology Enhances Prenatal Screening for 22q11.2 Microdeletion

Myriad Genetics

4 In a recent presentation, Dale Muzzey, PhD, Chief Scientific Officer at Myriad, summarized the findings this way: “We followed up with providers regarding their patients who screened positive for 22q. 5 Clear Benefits for Healthcare Providers and Patients The benefits to a high PPV are, well, myriad. Published 2023 Jan 6.

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

FDA Law

District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Several weeks later, also based on ability to pay, the U.S. Complaint ¶ 57. (The Complaint ¶ 58. Complaint ¶ 60.

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Beyond the Diagnosis: A Detailed Characterization of Outpatient Palliative Care Patients [Palliative and end-of-life care]

Annals of Family Medicine

Context Palliative medicine focuses on quality of life for patients with serious illnesses. Historically, palliative care has been predominantly provided in the inpatient setting, but there is a growing awareness that patients may also benefit from outpatient care. Results The patients in the SMC had a mean age of 71.

Patients 130
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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

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Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). We make a diagnosis. AlexSmithMD 1. It’s so different from therapy. Beth: Yeah.

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.

Medical 69