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BioWorld - Tuesday, December 16, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Illustration of Alzheimer’s in the brain.

Blood-based test for Alzheimer’s disease surpasses 96% accuracy

Feb. 23, 2024
By Tamra Sami
A new cutting-edge blood-based biomarker test developed by researchers at Hong Kong University of Science and Technology can detect early Alzheimer’s disease (AD) and mild cognitive impairment (MCI), with accuracy rates surpassing 96% and 87% respectively, and could be a game changer in detecting and treading early AD.
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SK-CC

Korea approves SK C&C’s AI solution to diagnose brain infarction

Feb. 22, 2024
By Marian (YoonJee) Chu
South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.
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WTO logo

Deadline nears with no consensus on broader WTO COVID-19 waiver

Feb. 20, 2024
By Mari Serebrov
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
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X-trodes Smart Skin

X-trodes receives FDA clearance for Smart Skin electrophysiological system

Feb. 20, 2024
By Shani Alexander
X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care.
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Shionogi Diagnostic support AI program

Shionogi, Fronteo developing AI diagnostic support models for dementia, depression

Feb. 16, 2024
By Tamra Sami
Shionogi & Co. Ltd. is partnering with Fronteo Inc. to develop artificial intelligence (AI)-based diagnostic tools to diagnose mental and neurological disorders more accurately.
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Freenome co-founder Riley Ennis

Freenome liberated with $254M infusion for cancer testing

Feb. 15, 2024
By Annette Boyle
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”
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HART esophageal implant

HART minimizes scarring associated with its regenerative esophageal implants

Feb. 14, 2024
By Simon Kerton
Holliston, Mass.-based Harvard Apparatus Regenerative Technology Inc. (HART) is seeking patent protection for synthetic structural support devices for use in esophageal tissue regeneration, in which the synthetic structural supports have been seeded with cells (e.g., mesenchymal stem cells) to form a cellular sheath on the supports’ outer surfaces.
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Johns Hopkins Univ. triage smart patch
Patents

Johns Hopkins researchers file for smart patch patient triage patent

Feb. 9, 2024
By Simon Kerton
A team of Johns Hopkins University researchers have filed for patent protection of a system and method to determine patient prioritization for triage during mass trauma events. The system and method may continuously monitor patient parameters to determine patient prioritization over time, which may improve the speed, quantity, and efficacy of life-saving interventions.
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Toku Clair platform

Toku receives CE, UKCA marks for cardio disease AI risk evaluation tool

Feb. 8, 2024
By Shani Alexander
Toku Inc. recently obtained CE and UKCA marks for its artificial intelligence (AI) technology, Clair, which evaluates the risk of cardiovascular disease (CVD) using retinal images captured during an eye exam.
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US flag, Department of Health and Human Services flags

Opportunities for IVD, vaccine makers in US vector-borne disease plan

Feb. 7, 2024
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero.
Read More
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