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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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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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Nuralogix Anura Magic Mirror

Magicmirror on the wall, who’s the healthiest of them all?

March 18, 2025
By Annette Boyle
Nuralogix Corp.’s Anura Magicmirror seeks to answer questions more important than relative beauty with health insights gained via transdermal optical imaging technology and AI-powered insights into more than 100 health metrics. If Snow White’s stepmother had possessed one, she might have realized that she wasn’t thinking clearly because of mental stress or low blood sugar levels and eaten an unpoisoned apple herself.
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Gavel and scales

Former Magellan officials enter guilty pleas in lead test prosecution

March 17, 2025
By Mark McCarty
Three former officials with Magellan Diagnostics Inc., have entered guilty pleas in connection with faulty tests for lead poisoning that were widely used across the U.S. between 2013 and 2017. While former CEO Amy Winslow and two others will not be sentenced until later this year, all three face possible prison terms of three years or more and fines of as much as $250,000, highlighting the hazards of a lack of scruples with regard to compliance with U.S. FDA regulations.
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MSInsight screen

MSInsight secures €1.6M for cancer diagnostic platform

March 17, 2025
By Shani Alexander
The €1.6 million (US$1.7 million) in seed funding that MSInsight SAS recently raised is vital for the next phase of growth of the company, Arnaud Cutivet, president and co-founder, told BioWorld. MSInsight is developing a software, MSIcare, which uses sequencing technology to detect microsatellite instability (MSI) in solid tumors and liquid biopsies.
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Liquid biopsy illustration

Liquid biopsy market flooded with opportunity

March 14, 2025
By Annette Boyle
With an at least $60 billion total addressable market, the liquid biopsy sector offers abundant opportunity for multiple companies to swim to the top. The six largest companies in the pool have just dipped their toes in the water, with a total penetration of only 10%, a white paper from RBC indicates.
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Gold dollar sign

Samsung life science fund invests $10M in C2N Diagnostics

March 14, 2025
By Marian (YoonJee) Chu
Samsung Life Science Fund made its first strategic investment of the year into C2N Diagnostics LLC, underscoring the rising potential of blood-based diagnostics in detecting and monitoring the risk of Alzheimer’s disease for the masses.
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Map of Europe, Medical Device Regulation (MDR) text

Team NB proposes conditional CE marks for MDR, IVDR

March 14, 2025
By Mark McCarty
The European Association of Medical Device Notified Bodies, also known as Team NB, has proposed the issuance of a conditional CE certificate for medical devices and in vitro diagnostics, a concept said to have existed in the legacy regulations as well. The question for industry is whether this mechanism can be used to aid in the backlog of devices under the Medical Device Regulation (MDR), a problem that is still front and center in the EU eight years after passage of the index legislation.
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