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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
Diagnostics RSS Feed RSS

US flag, gavel, book

FDA declines to appeal court loss in LDT litigation

June 2, 2025
By Mark McCarty
The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.
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DNA NGS genome sequencing

GC Genome plans $30M IPO to diversify genomic products, suppliers

May 27, 2025
By Marian (YoonJee) Chu
No Comments
GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
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Brain and neural networks
Neurology/psychiatric

A novel coumarin-based radiolabel for monoamine oxidase B in neurodegenerative disease

May 27, 2025
No Comments
Researchers at North China Electric Power University and collaborators have developed novel radiolabels for the membrane-bound monoamine oxidase-B that feature a coumarin core.
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SeeMe
Patents

Seeme helps measure, detect consciousness after TBI

May 23, 2025
By Simon Kerton
In what represents their first patenting, researchers from New York’s Stony Brook University filed for protection for development of a system and method that uses computer vision to analyze microscale facial movements in order to objectively help diagnose, monitor, and treat disorders of consciousness.
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Illustration of magnifying glass inspecting brain
Diagnostics

Toward in vivo imaging of α-synuclein aggregates using azocoumarin derivatives

May 21, 2025
No Comments
Being able to detect and monitor the aggregation of α-synuclein in situ could lead to more objective, earlier diagnosis of Parkinson’s disease as well as allow real-time monitoring of whether patients are responding to treatment.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Fujirebio Alzheimer’s test wins first FDA clearance

May 20, 2025
By Annette Boyle
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Fujirebio Alzheimer’s test wins first FDA clearance

May 19, 2025
By Annette Boyle
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
Read More
Zip p2 platform

Zip Diagnostics develops first rapid POC test for scabies

May 16, 2025
By Tamra Sami
Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
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urine testing device
Patents

Urine-testing device turns toilets into health trackers

May 16, 2025
By Simon Kerton
In what represents just the company’s third PCT filing, Houston-based Starling Medical Inc.’s co-founders, Hannah McKenney and William Hendricks, seek to gain further protection for their at-home urine diagnostic patient-monitoring platform that eliminates the traditional use of catching containers and dipsticks.
Read More
Diagnostics

ETH Zürich and Roche divulge new MAGL inhibitors

May 8, 2025
Scientists at ETH Zürich, F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. have synthesized fluorescent probes acting as monoglyceride lipase (MGLL; MAGL) inhibitors reported to be useful for diagnostic imaging of MAGL.
Read More
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