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BioWorld - Monday, December 29, 2025
Home » Topics » Medical devices and technologies » Diagnostics

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Global pandemic threat

Too little, too late: WHO panel says the world is vulnerable to another pandemic

May 18, 2022
By Lee Landenberger
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
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Labcorp Ondemand kid with blood collection stick for HbA1c

Labcorp expands DTC business with EUA for COVID-19, influenza and RSV test, launch of diabetes screening test

May 17, 2022
By Annette Boyle
The pandemic exponentially amplified the move to more patient-driven health care with at-home monitoring, wearable medical devices and telemedicine. Testing has arguably seen the greatest shift, led by emergency use authorizations (EUA) for dozens of rapid tests for SARS-CoV-2. Laboratory Corp. of American Holdings Inc. (Labcorp) stands to benefit even more from the trend with an EUA for an over-the-counter multiplex respiratory virus test and the launch of an at-home collection kit for testing hemoglobin A1c (HbA1c) this week.
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COVID-19 research illustration

US NIH COVID-19 technologies going global

May 12, 2022
By Mari Serebrov
In an effort to increase global access to COVID-19 technologies, the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool finalized a licensing agreement May 12 with the U.S. NIH for research tools, early stage vaccines and diagnostics.
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Digital illustration of U.S., coronavirus

Contamination at root of class I recall of Mesa Biotech’s Accula COVID test

May 10, 2022
By Mark McCarty
The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
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Device image

Oncohost’s $35M series C predicts expansion of Prophet study

May 10, 2022
By Annette Boyle
The short-term future is a little clearer for Israeli precision oncology startup Oncohost Ltd. now that it has closed a $35 million series C fundraising round. The new infusion more than doubled the previous amount raised, bringing total investment to more than $50 million. The company plans to use the funds to expand its PROPHETIC trial of the company’s machine learning-based host response profiling platform, Prophet, to additional locations worldwide and new indications.
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Global vaccine.png

WTO’s IP waiver reaches final stretch

May 10, 2022
By Mari Serebrov
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
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Global vaccine.png

WTO’s IP waiver reaches final stretch

May 4, 2022
By Mari Serebrov
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
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ATUSA device

FDA greenlights Isono Health’s wearable breast ultrasound system

May 3, 2022
By Annette Boyle
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
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Cancer cell, DNA illustration

Industry, Supercluster invest CA$17.8M to better diagnose cancer recurrence and relapse

April 29, 2022
By David Godkin
Canada’s federally-funded Digital Technology Supercluster is joining with industry to invest CA$17.8 million (US$13.9 million) in an artificial intelligence (AI)-powered technologies program to advance personalized treatment for patients with cancer.
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New HIF-2alpha PET tracer presented by University of Texas System

April 25, 2022
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