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

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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
Fallopian tubes, ovaries and uterus

Inoviq expands collaboration with UQ to develop exosome-based ovarian cancer screening test

April 22, 2022
By Tamra Sami
Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
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Genome illustration

China clarifies regulations on sharing human genetic resources

April 20, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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FDA icons

FDA revokes 5 COVID test EUAs at request of sponsors

April 19, 2022
By Mark McCarty
The U.S. FDA’s device center reported April 18 that it has revoked the emergency use authorizations (EUAs) for five tests for the SARS-CoV-2 virus, a seemingly significant reduction in the inventory of tests for the COVID-19 pandemic. However, the sponsor of the test in each of these revocations requested that the EUA be revoked, an indication that the market for some types of these tests is saturated.
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DNA illustration

China clarifies regulations on sharing human genetic resources

April 19, 2022
By Tamra Sami
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
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Coronavirus, lungs, hand holding stethoscope

FDA grants EUA for breath test for COVID, but impact on overall test volume is limited

April 18, 2022
By Mark McCarty
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
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