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BioWorld - Tuesday, December 16, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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New PET ligand allows in vivo pharmacological evaluation of agents targeting mutant HTT expression

Feb. 9, 2022
Leslie Yessenia Cieza Huane with MOSY device

Med-tech innovations included in The Royal Academy of Engineering’s LIF Global 2022 program

Feb. 8, 2022
By David Ho
The Royal Academy of Engineering in the U.K. has revealed a new batch of 70 entrepreneurs, including some developers of med-tech solutions, for its Leaders in Innovation Fellowships Global (LIF Global) program. This comes just two months after the LIF Advance edition of the initiative, which had 15 chosen. The selected entrepreneurs will receive equity-free support over the next six months from the training and mentorship program.
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Navidea sponsors research at Penn to evaluate Tc99m tilmanocept as prognostic marker in glioblastoma

Feb. 8, 2022
Cancer cells under magnifying glass

Study demonstrates pan-cancer detection from genetic and epigenetic biomarkers

Feb. 7, 2022
By Catherine Longworth
Scientists from Healthbiocare GmbH, System Biologie AG and the University of Austria have published data indicating pan-cancer detection could be achieved by combining genetic and epigenetic biomarkers in plasma. The scientists developed a classification model that distinguished between healthy subjects and patients with solid tumors with 95.4% accuracy, 97.9% sensitivity, and 80% specificity.
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EU flags in front of the Berlaymont building

Postmarket performance follow-up a key consideration in MDCG guidance for IVDs

Feb. 4, 2022
By Mark McCarty
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.
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Fetus, RNA concept image

Mirvie touts new data on preterm birth prediction for its personalized pregnancy health test

Feb. 4, 2022
By Catherine Longworth
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy.
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COVID tests will be free to US Medicare beneficiaries later this year

Feb. 3, 2022
By Mark McCarty
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
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DNA illustration

Biocaptiva gears up to test DNA capture device in clinical trials

Feb. 3, 2022
By Catherine Longworth
University of Edinburgh spinoff Biocaptiva Ltd. is taking its cell free DNA (cfDNA) capture device to clinical trials in 2022 following promising preclinical results. The company’s platform technology is designed to increase the quantity of cfDNA available for liquid biopsy testing. Current liquid biopsy practices obtain cfDNA via a venous blood draw but the concentration of tumor-derived ctDNA can be too low for comprehensive testing. Biocaptiva’ device emerged from research at the University of Edinburgh investigating liquid biopsy technologies.
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Group photo of Biofidelity staff

Biofidelity attracts $23M series A investment to launch lung cancer test

Feb. 2, 2022
By Catherine Longworth
Cancer diagnostics company Biofidelity Ltd. reported a $23 million series A+ investment round, led by Octopus Ventures with participation from SBI Investment Co. Ltd. and existing investors. Funds will be used for the commercial launch of the company’s first commercial assay Asypre-Lung. The oncology panel is designed to detect DNA mutations from tissue or liquid biopsy quicker than current approaches like gene sequencing.
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Pandemic lessons fuel reignition of US cancer moonshot

Feb. 2, 2022
By Mari Serebrov
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
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