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BioWorld - Friday, December 19, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Healgen COVID-Flu OTC test kit

FDA authorizes first home flu and COVID-19 combo test outside EUA

Oct. 8, 2024
By Holland Johnson
The U.S. FDA granted marketing authorization for Healgen Scientific LLC’s Rapid Check COVID-19/Flu A&B antigen test.
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Illustration of Victor Ambros and Gary Ruvkun
Biomarkers

Two win Nobel for microRNA work

Oct. 8, 2024
By Mar de Miguel
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its discoverers – Victor Ambros and Gary Ruvkun – the 2024 Nobel Prize in Physiology or Medicine “for the discovery of microRNA and its role in post-transcriptional gene regulation.”
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certis ai cancer biomarker
Patents

Certis files patent for AI platform to ID predictive cancer biomarkers

Oct. 7, 2024
By Simon Kerton
Certis Oncology Solutions Inc. filed for protection of its artificial intelligence platform that utilizes big data, statistical algorithms, and machine learning to predict drug efficacy based on gene expression biomarkers.
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El Camino Health FloPatch

Flosonics’ Flopatch helps reduce sepsis mortality from 30% to 5%

Oct. 7, 2024
By Annette Boyle
Implementation of Flosonics Medical Inc.’s Flopatch reduced sepsis-associated mortality more than 80% in a California public hospital, a case study showed. A wearable Doppler ultrasound device, Flopatch continuously assesses blood flow to guide fluid delivery and resuscitation in critically ill patients.
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Biomarkers

Nobel Prize in Physiology or Medicine for discovering microRNA

Oct. 7, 2024
By Mar de Miguel
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its authors Victor Ambros and Gary Ruvkun the 2024 Nobel Prize in Physiology or Medicine.
Read More
Illustration of Victor Ambros and Gary Ruvkun
Biomarkers

Two win Nobel for microRNA work

Oct. 7, 2024
By Mar de Miguel
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its discoverers – Victor Ambros and Gary Ruvkun – the 2024 Nobel Prize in Physiology or Medicine “for the discovery of microRNA and its role in post-transcriptional gene regulation.”
Read More
Human colon cancer cells.

FDA greenlights Exact Sciences’ Cologuard Plus

Oct. 4, 2024
By Annette Boyle
Exact Sciences Corp.’s Cologuard Plus received U.S. FDA pre-market approval as a non-invasive colorectal cancer home screening test. The next-generation, stool-based assay, developed in conjunction with the Mayo Clinic, reduces false positives by 30% compared to the original Cologuard test without diminishing its sensitivity for cancer or advanced adenomas.
Read More
Roches Cobas system and test

Roche launches breakthrough 12-target PCR test

Oct. 3, 2024
By Shani Alexander
Roche AG’s new test using its temperature-activated generation of signal technology is the next step in PCR evolution, Igor Kozlov, head of Reagent Research and Design at Roche Diagnostics Solutions, told BioWorld. The Cobas Respiratory flex test can detect up to 12 of the most common respiratory viruses using a single PCR test.
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Olympus Visera S

Olympus launches Visera S diagnostic platform in Europe, Asia

Oct. 2, 2024
By Marian (YoonJee) Chu
Tokyo-based Olympus Corp. launched a new video imaging platform called Visera S (OTV-S500) in Europe and select Asian countries September 2024 while advancing more rollouts for the product worldwide.
Read More
Kent Imaging SnapshotNIR

Kent Imaging looking to raise $25M for wound care devices

Oct. 1, 2024
By Shani Alexander
Kent Imaging Inc. is looking to raise $25 million in a series B financing round to expand the use of its imaging device for measuring wound and tissue oxygenation, and to support the launch of a new product, Pierre Lemire, CEO, told BioWorld.
Read More
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