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BioWorld - Sunday, January 11, 2026
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Test collection envelope

Visible Genomics offers genetic test for age-related macular degeneration

Sep. 11, 2020
By Mary Ellen Schneider
Visible Genomics has launched a set of noninvasive genetic tests aimed at assessing the overall risk of developing age-related macular degeneration (AMD) or progressing with the disease. AMD is a common condition that affects the part of the eye called the macula. It typically blurs the central vision used in tasks like reading and driving and develops around age 50.
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Software screenshot on laptop, computer monitor

RapidAI debuts Rapid Web App, wins ISO 27001 certification

Sep. 10, 2020
By Meg Bryant
RapidAI, which focuses on imaging for stroke, has launched the Rapid Web App to help stroke teams stay updated on imaging results and communicate securely. Using the app, team members can receive real-time browser notifications of new cases, preview Rapid results and source files and engage in workflow communications via a desktop or laptop computer.
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Microscope and coronavirus illustration

Shuren, Stenzel reiterate plea for LDT legislation in NEJM editorial

Sep. 10, 2020
By Mark McCarty
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
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Handshake dollar sign

Radiology Partners scoops up Mednax Radiology Solutions for $885M

Sep. 10, 2020
By Liz Hollis
Mednax Inc. has inked a definitive agreement through which Radiology Partners will acquire the former's radiology solutions group for $885 million, with an eye toward creating a provider of comprehensive radiology and teleradiology services. El Segundo, Calif.-based Radiology Partners is a physician-owned, on-site radiology practice that partners with about 1,600 radiologists providing services to nearly 1,300 hospitals, clinics and imaging centers across 26 states. When the transaction wraps up, the combined organization, operated under the Radiology Partners name, will include more than 2,400 radiology physicians who provide services in every state plus Washington.
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Australia map, flag

Australia to allow more self-test IVDs to be sold to consumers

Sep. 10, 2020
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.
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BioWorld MedTech’s Diagnostics Extra for Sept. 10, 2020

Sep. 10, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Deep learning aid for diagnosing TB in HIV patients; Self-collected swabs vs. health care worker collected for COVID-19 testing; SCAD vs. plaques in heart attacks; Diagnosing neuroblastoma in children.
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Ultra-sensitive antigen testing could help identify patients at risk for severe COVID-19

Sep. 10, 2020
Digital illustration of U.S., coronavirus

Ultra-sensitive antigen testing could help identify patients at risk for severe COVID-19

Sep. 9, 2020
By Mary Ellen Schneider
A new type of SARS-CoV-2 antigen test that relies on single molecule array technology may be able to help clinicians identify which patients are most likely to experience severe disease.
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Liver organoid
Multiple drugs, single model

Organoids enable due DILIgence on liver toxicity

Sep. 9, 2020
By Anette Breindl
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism.
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FDA approves Detectnet

Sep. 9, 2020
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