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BioWorld - Saturday, December 27, 2025
Home » Topics » Medical devices and technologies » Diagnostics

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Digital heart illustration

NMPA approves the first AI ECG diagnostic machine

Aug. 7, 2020
By Bryan Wong
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.
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Earth infected with pandemic

Neura sees the adoption of the Viruscore predictive testing solution

Aug. 7, 2020
By Liz Hollis
Neura Inc., which focuses on AI-powered behavioral intelligence that provides real-world insights for health organizations, governments and consumer brands, has revealed the adoption of its Viruscore COVID-19 predictive testing solution.
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Coronavirus vs U.S. wrecking balls

Harvard’s Mina says ‘archaic view’ of testing impeding cheap surveillance testing for COVID-19

Aug. 7, 2020
By Mark McCarty
The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.
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Various screenshots of software showing retinal images

Eyenuk gets FDA nod for AI-based diabetic retinopathy screening tool

Aug. 7, 2020
By Meg Bryant
People with diabetes are at risk of developing diabetic retinopathy (DR), an eye condition that can cause vision loss and blindness. However, early detection and treatment can slow its progress. To that end, the Food and Drug Administration has cleared the way for Eyenuk Inc. to market its Eyeart autonomous artificial intelligence (AI) system for DR screening in the U.S.
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BioWorld MedTech’s Diagnostics Extra for Aug. 6, 2020

Aug. 6, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Facilitating analysis of scratch wound healing tests; Advanced imaging in children; Picturing molecular alterations.
Read More

HTA presents new prostate cancer diagnosis probe [68Ga]DOTA-ANCP-PSMA

Aug. 6, 2020
U.S. FDA headquarters

Saliva-based tests for COVID-19 continue to perplex FDA, test developers

Aug. 5, 2020
By Mark McCarty
Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
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Topline data from phase II/III registration study of pegloprastide

Aug. 5, 2020

First-in-human study of [124I]JS-001 PET/CT and PET/MR in patients with melanoma

Aug. 5, 2020

AC Immune describes enhanced alpha-synuclein PET tracers

Aug. 5, 2020
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