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

Diagnostics
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Renalytix receives de novo authorization

July 6, 2023
By Annette Boyle
The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
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Adicon nets $52M in Hong Kong IPO, shares jump 12% on debut

July 6, 2023
By Doris Yu
Adicon Holdings Ltd. raised HK$409 million (US$52 million) in an initial public offering on the Hong Kong stock market. Its shares opened at HK$12.32, jumped 12% and closed at HK$13.8 on the first trading day. Hangzhou, China-based Adicon is among the top three independent clinical laboratory (ICL) service providers in China by total revenues. It offers testing services to hospitals and health check centres through a network of 33 self-operated laboratories across China.
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Pancreas
Diagnostics

New EDB-FN-targeted Gd-based contrast agent for PDAC disclosed

July 6, 2023
Researchers from the Chinese Academy of Medical Sciences and Peking Union Medical College reported on the development of a novel EDB-FN-targeted Gd-based contrast agent, named EDB-Gd-DOTA-Cy7, for imaging and treatment planning of pancreatic ductal adenocarcinoma (PDAC).
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Diagnostics

[11C]MGX-10S, a PET tracer for imaging GPR84-expressing myeloid cells in neuroinflammation

July 6, 2023
Researchers from Stanford University and affiliated organizations have provided details on the discovery and preclinical evaluation of [11C]MGX-10S, a novel PET tracer for GPR84, which is a G protein-coupled receptor (GPCR) expressed predominately on myeloid cells.
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UK’s NICE says AI-assisted detection of lung nodules not ready for prime time

July 5, 2023
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) released several draft and final health technology assessments on July 5, including a review of the use of artificial intelligence (AI) to aid in the detection of lung nodules in CT images. The agency said that more research is needed before it will be able to provide an unqualified endorsement because of a relative lack of data that could be reliably generalized from clinical study subjects to the broader U.K. population at large.
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Digital eye illustration

Retinal imaging sees the future of CKD

July 5, 2023
By Annette Boyle
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
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Lumos Febridx

Lumos gains FDA nod on third try for Febridx 510(k) as stock rockets 327%

July 5, 2023
By Tamra Sami
Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
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Illustration of prescription pill bottle with DNA on the label.

EAN 2023: Even after breakthroughs, gains need defending

July 5, 2023
By Anette Breindl
At the 2023 Annual Congress of the European Academy of Neurology, Mary Reilly described the relationship between bench and bedside as “a continuous circle of translation,” with each cycle beginning with patients and their needs.
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Brain
Diagnostics

(R)-[18F]YH-134, a novel reversible radiotracer for imaging and quantification of MAGL

July 5, 2023
Monoacylglycerol lipase (MAGL) is a key regulator of the endocannabinoid system (ECS), which has a critical neuromodulatory involvement in numerous functional mechanisms in the CNS. Based on this, MAGL is considered a promising therapeutic target in neuroinflammation and neurodegeneration. Researchers from ETH Zürich and affiliated organizations have recently presented their work on (R)-[18F]YH-134, a novel reversible radiotracer for imaging MAGL in the brain.
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Brain illustration
Diagnostics

Novel dopamine D3 receptor PET tracer for brain imaging reported

July 5, 2023
Dopamine D3 receptors play a relevant role in the CNS modulating neurological activity, and its dysfunction is linked to disorders such as schizophrenia, drug abuse or Parkinson’s disease. There is a need for blood-brain barrier (BBB)-penetrant D3 receptor radiotracers with high brain uptake to be used for neurological and neuropsychiatric disease diagnosis.
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