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BioWorld - Wednesday, December 24, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Tau neuron illustration
Diagnostics

[18F]FA1, a tau-PET radiotracer with excellent affinity and selectivity

Jan. 13, 2025
Work at Beijing Normal University and affiliated organizations has led to the discovery and preclinical characterization of a novel tau-PET radiotracer for Alzheimer’s disease (AD).
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soft microelectrode
Patents

Bioresorbable microelectrode array implant for cardiac conditions

Jan. 10, 2025
By Simon Kerton
Researchers from The George Washington University and Northwestern University filed for protection of a bioresorbable, transparent, microelectrode array (MEA) technology that they believe offers unique advantages.
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Illustration of female reproductive system under magnifying glass

Proteomics develops test that distinguishes endometriosis stages

Jan. 9, 2025
By Tamra Sami
Women with endometriosis may soon be able to have a simple blood test to diagnose their disease thanks to a breakthrough by Proteomics International Ltd. that has developed a plasma protein biomarker panel that identifies all stages of endometriosis.
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Masimo MightySat pulse ox

FDA forcing industry’s hand on pulse-ox sensitivity to pigmentation

Jan. 7, 2025
By Mark McCarty
The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these questions. The draft guidance recommends that new and existing devices be evaluated to establish performance across different pigmentations, a development that would address concerns among clinicians and patients alike.
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Illustration of a cluster of ovarian cancer cells
Cancer

New AI-based models better than humans at diagnosing ovarian cancer

Jan. 7, 2025
By Shani Alexander
Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners.
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Transmission electron micrograph of HIV particles

As STIs explode, at-home testing reduces diagnostic barriers

Jan. 6, 2025
By Annette Boyle
For more than a decade, HIV remained the only sexually transmitted infection (STI) with U.S. FDA approval of at-home sample collection, but a growing number of tests for sexually transmitted infections have received the regulatory greenlight for patients to swab themselves in the privacy of their own homes in recent years. With STIs reaching levels not seen in decades, regulators and physicians hope that the move will increase diagnostic rates and reduce disease spread by overcoming stigma and access barriers.
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South Korean won

AI cancer firm Oncocross debuts with $60M IPO on Kosdaq

Dec. 24, 2024
By Marian (YoonJee) Chu
AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).
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Acryl

Acryl cleared as Korea’s first AI DTx to screen, diagnose depression

Dec. 23, 2024
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.
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DermR collection device

Skin cancer study: Dermr patch as effective as skin biopsy

Dec. 20, 2024
By Tamra Sami
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.
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3D structure model of α-synuclein
Diagnostics

Candidate tracer for α-synuclein imaging falls flat

Dec. 20, 2024
In a recently published study, researchers from the University of Pennsylvania and collaborators aimed to identify compounds with high affinity to α-synuclein aggregates and high selectivity toward pathological α-synuclein compared to other brain targets.
Read More
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