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BioWorld - Friday, January 2, 2026
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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U.S. Capitol building

Advamed’s Van Meter: ‘Time is now to act’ on LDT regulatory reform

March 9, 2020
By Mark McCarty
The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.
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Head filled with digital data

Proscia, UCSF partner to develop AI-based digital pathology starting with prostate cancer

March 5, 2020
By Stacy Lawrence
AI-based, digital pathology startup Proscia Inc. has partnered with the University of California at San Francisco (UCSF) to advance the practice of pathology via artificial intelligence (AI). The pair will start with prostate cancer and then plan to move on to validate approaches in several additional pathology subspecialties.
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3-5-Infervision-CT-COVID-19.png

China uses AI in medical imaging to speed up COVID-19 diagnosis

March 5, 2020
By Elise Mak
BEIJING – More and more companies and researchers in China are rolling out artificial intelligence (AI)-based systems that can process hundreds of computed tomography (CT) images in seconds to speed up diagnosis of COVID-19 and assist in its containment.
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New phase I trial studies imaging agent I-124 M5A to detect liver metastases from colorectal cancer

March 5, 2020
Europe under magnifier/petri dish with coronavirus

COVID-19: EU launches response team to coordinate efforts

March 3, 2020
By Nuala Moran
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
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Rows of red and blue game pieces with hybrid center piece

Thermo Fisher to buy molecular diagnostics company Qiagen for $11.5B

March 3, 2020
By Liz Hollis
Thermo Fisher Scientific Inc., of Waltham, Mass., has made a bold play in the molecular diagnostics market, including infectious disease testing, with its proposed $11.5 billion acquisition of Qiagen NV, of Venlo, Netherlands. Word of the deal comes after reports late last year that named Thermo Fisher as a potential suitor for Qiagen. However, in late December, Qiagen said it had wrapped up a review of potential strategic alternatives and decided its standalone business plan represented the best opportunity for value creation.
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3-3-Xatek-clotchip.png

Xatek wins breakthrough status for portable clotting sensor

March 3, 2020
By Meg Bryant
With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.
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Cancer cell, DNA illustration

Todos Medical sets sights on COVID-19 test market

March 2, 2020
By Meg Bryant
New York and Rehovot, Israel-based in vitro diagnostics startup Todos Medical Ltd. is developing blood tests for the early detection of cancer and neurodegenerative diseases using Fourier-transform infrared (FTIR) spectroscopy. Now the company is looking to apply the technology in diagnosing infections, including the novel coronavirus, COVID-19.
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Europe under magnifier/petri dish with coronavirus

COVID-19: EU launches response team to coordinate efforts

March 2, 2020
By Nuala Moran
LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.
Read More

FDA posts IIE guidance for clinical lab development of COVID-19 tests

March 2, 2020
By Mark McCarty
The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.
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