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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Photomicrograph of liver biopsy in a patient with cirrhosis, showing bridging septal fibrosis and regenerative nodules.

Mursla Evoliver biopsy blood test granted breakthrough designation

April 25, 2025
By Shani Alexander
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.
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Illustration of diseased kidney

Kidneyintelx test leads to increased use of SGLT2 inhibitors

April 23, 2025
By Shani Alexander
The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.
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Neuranics technologies

Neuranics raises $8M for magnetic sensing technology

April 16, 2025
By Shani Alexander
Neuranics Ltd. recently raised $8 million in seed funding which is “extremely important” for the company as it looks to scale its magnetic sensing technology, which detects muscle activity without touching the skin, Noel McKenna, CEO told BioWorld. “The funds will help accelerate our go to market strategy and advance our R&D roadmap,” he said.
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Lunit Insight MMG

AI-enhanced mammogram readings are better, but ignored

April 10, 2025
By Marian (YoonJee) Chu
AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
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CGM sensor
Patents

Patent filed for multiweek, multitarget CGM-like wearable sensor

April 10, 2025
By Simon Kerton
Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
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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.
Read More
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