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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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DNA, fetus illustration

Igene launches noninvasive prenatal test for fetal RhD status in Asia

June 18, 2020
By David Ho
HONG KONG – Singapore-based Igene Laboratory, a wholly owned subsidiary of Inex Innovate Pte. Ltd., has launched a noninvasive prenatal test (NIPT) that assesses fetal Rhesus factor (RhD) status from a maternal blood sample.
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Product image

Ceribell’s portable EEG helping to detect seizures in COVID-19 patients

June 18, 2020
By Meg Bryant
The potential for neurological complications, including seizures and stroke, is a growing concern with COVID-19 patients. To ensure rapid diagnosis and treatment, Ceribell Inc., a Mountain View, Calif.-based startup, is deploying its cloud-linked, portable electroencephalogram (EEG) device to enable EEG assessments in minutes in emergency rooms and intensive care units.
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Hand adding piece to puzzle

Illumina acquires Dutch cloud software startup Bluebee to enhance genomic data analysis

June 18, 2020
By Stacy Lawrence
San Diego-based Illumina Inc. is synonymous with next-generation sequencing (NGS) equipment. But when it comes to dealmaking, the genomics giant is focused largely on software to make its results more useful, accessible and affordable. It has acquired cloud-based software startup Bluebee Holding BV in its latest move on this front.
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BioWorld MedTech’s Diagnostics Extra for June 18, 2020

June 18, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of pulmonary hypertension; A web-based COVID-19 assessment tool; Discovering pharmacological enzyme activators.
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Empty waiting room

Poised for second round, pandemic creates backlog of untreated diseases

June 18, 2020
By Mari Serebrov
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits.
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U.S. FDA headquarters

FDA lays out top priorities for COVID-19 testing, weighs in on asymptomatic screening

June 17, 2020
By Stacy Lawrence
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
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Resistanceplus product packaging

Australia’s Speedx partners with Roche to expand access to qPCR antibiotic resistance tests

June 17, 2020
By Tamra Sami
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche Holding AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
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FDA icons

Back to ‘normal’? FDA adcom meets, but questions loom over others

June 17, 2020
By Mari Serebrov
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
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Cancer cell, DNA illustration

Lisen unveils new epigenetic solution for early cancer detection

June 16, 2020
By David Ho
HONG KONG – China and U.S.-based Lisen Imprinting Diagnostics Inc. has unveiled its Quantitative Chromogenic Imprinted Gene In-Situ Hybridization (QCIGISH) technology, a novel approach for identifying, visualizing and quantifying the biallelic and multiallelic expressions of an imprinted gene panel associated with cancer status.
Read More
Radiologist using imaging software
Strategy transformation

Agfa-Gevaert sells part of its health care division for $1.1B to focus on IT imaging activities

June 16, 2020
By Bernard Banga
PARIS – Agfa-Gevaert Group NV, of Mortsel, Belgium, has sold parts of its health care information technology (IT) business to Italy’s Dedalus Holding SpA for $1.1 billion. The divested interests include health care information solutions activities and integrated care activities in Germany, Austria, Switzerland, France and Brazil, as well as certain IT imaging activities in these territories. It represents about half of Agfa Healthcare’s business.
Read More
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