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BioWorld - Saturday, December 20, 2025
Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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heartflow-diagnostic-8may24.jpg

Heartflow reports 63% mortality reduction with FFRCT-guided care in PAD

May 7, 2024
By Holland Johnson
Heartflow Inc. reported exceptional results in a study published in the Journal of Vascular Surgery that revealed coronary computed tomography angiography with fractional flow reserve care reduced mortality by more than 60% at five years in patients with peripheral arterial disease undergoing major vascular surgery, far surpassing the current standard of care.
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Leech inspired blood collection device

Micro-sampling device takes lessons from leeches

May 7, 2024
By Shani Alexander
Researchers have developed a new blood collection device inspired by the behavior of a leech which attaches itself to a host, penetrates their skin with its teeth and swallows to create negative pressure drawing blood.
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3D rendering conceptualizing theranostics
Cancer

[64Cu]PD-32766 and [177Lu]PD-32766, a new theranostic pair for CAIX-expressing tumors

May 6, 2024
Researchers from Peptidream Inc. presented preclinical characterization of novel carbonic anhydrase IX (CAIX)-targeting radiopeptides, [64Cu]PD-32766 and [177Lu]PD-32766, being developed for the diagnosis and treatment of clear cell renal cell carcinoma (ccRCC), respectively.
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Blood cells and bacteria

Cytovale’s Intellisep rules out sepsis in 97.5% of cases

May 3, 2024
By Annette Boyle
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
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U-RHYTHM

Dynamic Therapeutics aims to transform hormone measurement with U-Rhythm

May 3, 2024
By Shani Alexander
Dynamic Therapeutics Ltd. is looking to commercialize its U-Rhythm technology which it hopes will transform the way hormones are measured. U-Rhythm, a portable device which collects biochemical samples from the patient throughout the day, will significantly change the diagnosis and treatment of many diseases, Stafford Lightman, co-founder of Dynamic Therapeutics told BioWorld.
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Hand pointing at digital M&A screen

Quest and Pathai sign multipart collaboration

May 2, 2024
By Annette Boyle
Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.
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Tiger mosquito
Biomarkers

sST2 as prognostic biomarker for severe dengue in adult patients

May 2, 2024
Researchers from Tan Tock Seng Hospital presented data from a study investigating the utility of soluble suppressor of tumorigenicity-2 (sST2) as early prognostic biomarker of severe dengue.
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ai-tbi
Patents

Patent filed for AI use in early detection of neonatal brain injuries

April 30, 2024
By Simon Kerton
In what represents its first patenting, PBSF Inc. filed for protection of brain monitoring and neuroprotection strategies for infants at high risk on a large scale.
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Illustration of tick penetrating skin into blood stream
Biomarkers

MCP-3 predicts prognosis of severe fever with thrombocytopenia syndrome

April 30, 2024
Severe fever with thrombocytopenia syndrome (SFTS) is a tick-borne disease that results from an infection with the SFTS virus, with a case fatality rate of 6.1% to 21.8%. Identifying critically ill patients at the early stages is crucial for clinical management.
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Purple-tinted test tubes and dropper

Final LDT rule likely to favor larger players in lab space

April 29, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
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