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Medical Devices & Diagnostics

Medical Devices & Diagnostics

How Network Bio and NVIDIA plan to turn cell-free RNA into disease-spanning medical intelligence

Network Bio and NVIDIA are scaling a cfRNA foundation model for disease detection, biomarker discovery and drug development across biobanks.

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Medical Devices & Diagnostics

Aztron Medtech just doubled TendMIN’s U.S. procedure count. Can the next financing round turn early adoption into scale?

Aztron Medtech wins a Taiwan Presidential Award as TendMIN passes 200 U.S. procedures and the company prepares its next financing round.

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Medical Devices & Diagnostics

Cardio Diagnostics now controls its own cardiac test lab, but can CLIA certification unlock meaningful scale?

Cardio Diagnostics starts in-house Epi+Gen CHD and PrecisionCHD processing in Iowa. See what CLIA certification means for margins and adoption.

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Medical Devices & Diagnostics

ATEV beats AV fistula in Phase 3 dialysis trial as Humacyte prepares FDA filing

Humacyte’s ATEV beats AV fistula in Phase 3 dialysis access testing as peer-reviewed V007 data strengthen its planned 2026 FDA filing.

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Medical Devices & Diagnostics

Can one blood test reveal which cells are aging fastest? Vero brings Stanford Cell Clock into OrganAge

Vero adds Stanford Cell Clock technology to OrganAge ahead of a 2027 rollout, while clinical validation remains the key commercial test.

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Medical Devices & Diagnostics

Gemelli Biotech IBS-Smart study finds lower diagnostic costs in patients with suspected IBS

Gemelli Biotech’s IBS-Smart and Trio-Smart were linked to lower captured diagnostic costs in a 219-patient IBS study, but causality remains unproven.

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Medical Devices & Diagnostics

InformedDNA has now divested two businesses in 2026. Why is everything pointing toward DNAimpact?

InformedDNA divests its genetic testing utilization management unit to Zyter, sharpening its DNAimpact precision health strategy after two 2026 deals.

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Medical Devices & Diagnostics

FDA clears Vesalio pVasc NET for peripheral mechanical thrombectomy

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Vesalio for pVasc NET, a peripheral mechanical thrombectomy device that combines a self-expanding clot retriever with a fine-pore, dual-layer filter positioned at its distal end. The FDA classified the device as substantially equivalent through the Special 510(k) pathway on August 5, 2026. Vesalio

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Medical Devices & Diagnostics

FDA clears Samsung Galaxy Buds software as an over-the-counter hearing aid

Samsung Electronics has received United States Food and Drug Administration (FDA) clearance for software that allows compatible Galaxy Buds to function as self-fitting, over-the-counter hearing aids for adults with perceived mild to moderate hearing impairment. The Hearing Aid Feature will initially be available on Galaxy Buds3 Pro and Galaxy Buds4 Pro in the United States

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Medical Devices & Diagnostics

What FDA’s blue-light cystoscopy reclassification could mean for Photocure and Cysview

FDA’s Class II proposal could lower a major equipment barrier for Photocure’s Cysview. See what the regulatory shift could mean for US adoption.

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