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BioWorld - Monday, June 22, 2026
Home » Topics » Medical technology » Diagnostics

Diagnostics
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FDA authorizes first direct-to-consumer COVID-19 test system

Dec. 9, 2020
By Holland Johnson
The U.S. FDA authorized Burlington, N.C.-based Laboratory Corporation of America Holdings’ (Labcorp’s) Pixel COVID-19 test home collection kit for use by any individual 18 years and older without a prescription.
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Software screenshot

Paige obtains CE marks for breast, prostate cancer options

Dec. 9, 2020
By Liz Hollis
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
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Cyber eye illustration

Retinai partners with Novartis for use of AI in ophthalmology trials

Dec. 8, 2020
By Nuala Moran
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
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Erapid illustration

IQ Group Global licenses Harvard Erapid technology for inexpensive, point-of-care COVID test

Dec. 4, 2020
By Annette Boyle
Harvard University’s Wyss Institute for Biologically Inspired Engineering licensed its Erapid electrochemical sensing platform to IQ Group Global to integrate with the Australian consortium’s transistor technology in a SARS-CoV-2 test. The combined solution could greatly simplify serological testing for the virus and help monitor immunity in individuals and populations over time.
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Acquisition target

Olympus buying Veran Medical for up to $340M

Dec. 4, 2020
By Liz Hollis
Olympus Corp. has unveiled its plans to acquire Veran Medical Technologies Inc. for up to $340 million. The buy will go through Olympus Corp. of the Americas (OCA) and is part of the company’s corporate strategy revealed in November 2019. It marks the second M&A-related announcement in about a month.
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Doctor using Strokeviewer LVO on smartphone

FDA clears Nico.lab’s AI-powered Strokeviewer to speed stroke care

Dec. 3, 2020
By Annette Boyle
For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.
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BioWorld MedTech’s Diagnostics Extra for Dec. 3, 2020

Dec. 3, 2020
By Anette Breindl and Meg Bryant
Keeping you up to date on recent developments in diagnostics, including: Quantum nanodiamonds could improve disease detection; Field-friendly approach could aid in malaria control; Equine encephalitis’ entry elucidated.
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FDA approves [68]Ga-PSMA-11 for PET imaging of PSMA-positive lesions in prostate cancer

Dec. 3, 2020
Novel coronavirus SARS-CoV-2

Chembio looks for share of competitive Brazilian market for SARS-CoV-2 tests

Dec. 2, 2020
By Sergio Held
CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world.
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Bluestar Genomics, University of Chicago see publication of 5hmC map

Dec. 2, 2020
By Liz Hollis
Bluestar Genomics Inc. and the University of Chicago revealed the publication of a genome-wide 5-hydroxymethylcytosine (5hmC) map across multiple human tissue types. In the report, published Dec. 2, 2020, in Nature Communications, the researchers detailed the development of the map by characterizing the genomic distributions of 5hmC in 19 human tissues derived from 10 organ systems.
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