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BioWorld - Saturday, December 20, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Earth infected with pandemic

Pandemic highlights need for multiplex testing as fatalities exhibit high rates of co-infection

Sep. 18, 2020
By Mark McCarty
Next-generation sequencing may help provide clinicians with a speedier answer as to the identity of the second pathogen, a service that may prove critical to suppressing the fatality rate in this and in future pandemics, according to Robert Schlaberg, chief medical officer of IDbyDNA Inc., of Salt Lake City.
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M&A cityscape

Qiagen purchases balance of Neumodx Molecular for $248M

Sep. 18, 2020
By Annette Boyle
Just weeks after rejecting Thermo Fisher Scientific Inc.'s overtures, Qiagen NV completed its own deal – the acquisition of the final 80.1% of diagnostics instruments company Neumodx Molecular Inc. for $248 million in cash. Qiagen, based in Hilden, Germany, bought a 19.9% stake in Neumodx back in 2018 with the option to purchase the rest for $234 million. With U.S. regulatory approval recently obtained, the deal closed with an additional $14 million in customary adjustments for cash, indebtedness, and transaction costs.
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Coronavirus vs U.S. wrecking balls

FDA’s Stenzel: Agency willing to be ‘very flexible’ for at-home COVID-19 test

Sep. 17, 2020
By Mark McCarty
The diagnostic industry in the U.S. and elsewhere has scrambled to keep up with the COVID-19 pandemic, and one of the key developments will be a test that can be used at home without medical supervision. However, Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the Sept. 16 diagnostic town hall that the agency is keen on authorizing such a test, but has yet to receive any emergency use authorization filings. “We want to see a home test submission, and we’re willing to be very flexible here,” Stenzel said.
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Rocket launch illustration

Olive Diagnostics emerges from stealth with AI-assisted home urinalysis device

Sep. 17, 2020
By Meg Bryant
Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.
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Vocus PTR-TOF in the hospital

French researchers test new breath test to detect COVID-19

Sep. 17, 2020
By Bernard Banga
PARIS – Soon, a machine, as quick and simple as a breathalyzer, could be used to detect COVID-19 from molecules present in exhaled air. The research team from Institut de recherches sur la catalyse et l’environnement de Lyon (IRCELYON – Lyon Institute for Research on Catalysis and the Environment) is investigating the analysis of volatile organic compounds (VOCs) found in exhaled breath for COVID-19 detection.
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BioWorld MedTech’s Diagnostics Extra for Sept. 17, 2020

Sep. 17, 2020
By Meg Bryant and Anette Breindl
Keeping you up to date on recent developments in diagnostics, including: Intensive care scoring systems outperform miRNA in sepsis diagnosis; Report: AI falls short of potential in health care; Angiopoietin trouble can lead to lymphedema.
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Screen on Fitbit Sense reads "Take heart rhythm assessment"

Wearables step up their game with continued move from wellness apps to health monitors

Sep. 16, 2020
By Annette Boyle
Fitbit Inc. and Apple Inc. picked up the pace in their race to put health monitoring apps on wrists everywhere with Fitbit gaining 510(k) clearance from the U.S. FDA for its new ECG app for the Fitbit Sense and Apple revealing the blood oxygen sensor built into its Series 6 watch this week. The new apps join a growing array of technological advances that permit wearable devices to track and record a range of health metrics.
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IRDye800CW-nimotuzumab enters phase I/II study for image-guided lung cancer surgery

Sep. 16, 2020
Ribbons of digital data

Biopharma companies utilizing artificial intelligence for drug research

Sep. 15, 2020
By Peter Winter
The BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 37% year-to-date.
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SARS-CoV-2, neutralizing antibody diagram

Siemens Healthineers leads effort to define COVID-19 immunity with CDC, JRC

Sep. 15, 2020
By Annette Boyle
Siemens Healthineers AG snagged a key role in the mystery playing out across the world's pandemic stage – what do antibody test results mean in terms of immunity to SARS-CoV-2 and how do different tests assessing different proteins compare? The U.S. CDC and the Joint Research Centre (JRC) of the European Commission tapped the Erlanger, Germany-based company to take the lead in developing a process to standardize antibody assays.
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