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BioWorld - Tuesday, June 10, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Woman scanning test tubes in the lab

MDCG downgrades risk classification for COVID-19 tests

April 9, 2025
By Mark McCarty
The EU’s Medical Devices Coordination Group (MDCG) issued another revision of its guidance for risk classification for in vitro diagnostics — the fourth such rewrite of a guidance that came out in 2020.
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Art concept for medical research
Substance use & poisoning

Ignite Biomedical, Liquid Biosciences discover new biomarkers for substance use disorder

April 9, 2025
Ignite Biomedical Inc. and Liquid Biosciences have announced the discovery of biomarkers to diagnose substance use disorder (SUD). The set of biomarkers includes some that have not previously been associated with addiction and spans all 6 SUDs (opioid, cocaine, methamphetamine, alcohol, nicotine and cannabis use disorders).
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ai autism
Patents

Researchers use generative AI for autism diagnosis

April 8, 2025
By Simon Kerton
Researchers from George Washington University filed for protection of a system and method that leverages generative models, specifically Variational Autoencoders, to conduct functional connectivity analysis from functional magnetic resonance imaging scans.
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US flag, gavel, book

Diopsys agrees to $14M settlement over FCA allegations

April 7, 2025
By Mark McCarty
Diopsys Inc. agreed to pay $14.25 million to settle allegations it violated the False Claims Act (FCA) in encouraging the unnecessary use of the company’s Nova device for retinal testing.
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AI-generated illustration of DNA double helix

FTC eyeing 23andme’s disposition of genomic data

April 1, 2025
By Mark McCarty
The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.
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U.S. flag on columned building

FDA’s loss in lawsuit opens door to LDT promotion

April 1, 2025
By Mark McCarty
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
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Blood pressure gauge, ECG and medication
ACC.25

AI-enhanced ECG readings beat clinicians and labs in identifying MI

March 31, 2025
By Annette Boyle
When every minute matters, quickly determining which patients in the emergency department need urgent care for myocardial infarction can save lives. Researchers at the University Hospital Münster in Münster, Germany, developed a deep learning model that can detect features on electrocardiograms that more accurately identifies which patients require urgent revascularization than clinicians and provides results faster than high-sensitivity troponin lab tests.
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Medically accurate illustration of a baby in the womb of a pregnant mother

AI used to ID abnormalities in unborn babies

March 31, 2025
By Shani Alexander
The use of an AI tool could speed up the time it takes to do pregnancy scans by almost half and it is still able to identify any abnormalities in the fetus, researchers found. Results from a study showed the AI tool used to assist with 20-week pregnancy scans reduced the scan length by more than 40% and still maintained the same accuracy and reliability of diagnoses.
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Illustration of tumor on kidney

Elypta’s urine-based test shows recurrence of kidney cancer

March 26, 2025
By Shani Alexander
Elypta AB’s urine-based test correctly identified 90% of patients whose kidney cancer had returned, according to results from an ongoing study. The company’s metabolism-based liquid biopsy platform, which measures glycosaminoglycan biomarkers to detect cancer-specific signatures and uses algorithms to deliver clinically useful scores, could transform the lives of patients with kidney cancer.
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WO2025049953-A1, “Conductive microwire-based biochemical sensors for real-time neurological monitoring.”

Neurothread biosignal monitoring could sew up neurological diagnoses

March 20, 2025
By Simon Kerton
Researchers from The Ohio State University have filed for protection of Neurothread, a wire-type neurotransmitter-sensing platform that utilizes the cross-section of commercially available ultrathin microwires as microelectrodes.
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