News

FDA Issues Draft Guidance for Using RWD in Medical Device Regulation

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On December 18, 2023, the United States Food and Drug Administration (FDA) published a draft guidance called “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical...

Minimizing the Impact of Bias in Healthcare Algorithms

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Last week, researchers published a special communications article in JAMA Network Open outlining principles to address and minimize the impacts of racial and ethnic bias in healthcare algorithms. The...

Researchers Identify the Cause of Morning Sickness

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On December 13, 2023, scientists published a study in Nature that identified a risk factor for morning sickness, also called hyperemesis gravidarum. The condition causes severe nausea and vomiting...

Abortion Rights on the Line Again as SCOTUS Hears Mifepristone Case

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On December 13, 2023, the Supreme Court of the United States (SCOTUS) agreed to review an August case whose appeals court decision restricted access to mifepristone, one of the two drugs used for...

Texas Supreme Court Overturns Abortion Decision from Lower Court

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Yesterday, December 11, 2023, the Texas Supreme Court issued a ruling that overturned a lower court’s decision to grant Kate Cox an abortion. The lower court decision was issued last Thursday and...

Ophthalmic Scans Provide Insight into Kidney Health

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Earlier this week, researchers at the University of Edinburgh published an article in Nature Communications revealing that choroidal and retinal thinning may be biomarkers for chronic kidney disease...

Ultrasound Technology May Provide a New Vaccine Delivery Method

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Earlier this week, at Acoustics 2023 Sydney, a doctoral researcher at the University of Oxford’s Institute of Biomedical Engineering, Darcy Dunn–Lawless, discussed his research on a...

Researchers Identify Potential Cause of Hypertension-Induced Dementia

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Yesterday, the National Institutes of Health (NIH) issued a press release identifying a potential pathway for hypertension-induced dementia. The announcement cites a study published in Nature...

Overdose Deaths Increased in Postpartum Women from 2018 to 2021

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A report published last week in JAMA Psychiatry revealed changing patterns in overdose deaths among postpartum women. The study — funded by the National Institute on Drug Abuse (NIDA), a part of...

FDA Investigates Safety of CAR T-Cell Therapy

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In a safety notice published on November 28, 2022, the United States Food and Drug Administration (FDA) announced an investigation into the safety of chimeric antigen receptor (CAR) T-cell...

AMA Publishes Guidance on AI Development, Deployment, Use

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Yesterday, November 28, 2023, the American Medical Association (AMA) announced its Principles for Augmented Intelligence Development, Deployment, and Use. The document provides a roadmap for the...

AstraZeneca Launches Evinova to Advance Digital Health Solutions

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AstraZeneca has unveiled Evinova, a pioneering health-tech business dedicated to accelerating innovation across the life sciences sector. Evinova — positioned as a separate entity within...

Quest, Universal DX Collaborate to Advance Colorectal Cancer Screening

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On November 20, 2023, Universal DX (UDX), a biotechnology company, announced its collaboration with Quest Diagnostics, one of the two most significant lab services in the United States, to study,...

March of Dimes Gives US D+ Premature Birth Grade on 2023 Report Card

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Recently, March of Dimes released its annual report card on maternal and infant outcomes across the United States and its territories, highlighting that the US received a D+ for premature birth, with a...

FDA Authorizes First Chlamydia, Gonorrhea At-Home Sample Test

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On Wednesday, the United States Food and Drug Administration (FDA) authorized the Simple 2 Test manufactured by LetsGetChecked. The test is the first authorized chlamydia and gonorrhea diagnostic tool...

Gene Editing Technology Could Treat Hypercholesterolemia

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On Sunday, November 12, 2023, Verve Therapeutics presented the results of an ongoing clinical trial using gene therapy to treat uncontrolled high cholesterol, atherosclerotic cardiovascular disease,...

NIH Researchers Identify Sleep Deficiency as a T2D Risk Factor

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Yesterday, the National Institutes of Health (NIH) announced the results of a study that identified chronic sleep deficiency as a risk factor for type 2 diabetes (T2D). The study, published in Diabetes...

Johnson and Johnson Reveals General Surgery Robot Timeline

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Yesterday, Johnson and Johnson MedTech issued a press release to its investors and the public detailing the timeline for its general surgery robot. According to the announcement, the company intends to...

November 2023 Elections Mark 3 Big Wins for Abortion Rights

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On November 7, 2023, three states, Ohio, Kentucky, and Virginia, voted in favor of maintaining abortion rights. Although policy changes were only on the ballot in Ohio, votes in Kentucky and Virginia...

ASRM Redefines Infertility, Adding Sexual Orientation, Relationships

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In an attempt to develop a more inclusive and comprehensive definition of infertility, the American Society for Reproductive Medicine (ASRM) has modified the description to include people unable to...