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Medical Devices & Diagnostics

Medical Devices & Diagnostics

Could CABG stop depending on harvested veins? Vascudyne’s 18-month data strengthen the case.

A Nature Communications study found Vascudyne’s externally supported bioengineered vessel remained patent for up to 550 days in sheep, including a year without anticoagulation.

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Medical Devices & Diagnostics

OrganOx metra gains a reimbursement tailwind as NICE backs machine perfusion across NHS liver transplantation

NICE has supported routine NHS access to ex-situ liver machine perfusion, potentially reducing funding variation for technology designed to assess and preserve donor organs before transplantation.

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Medical Devices & Diagnostics

Kandu’s IpsiHand BCI improves chronic stroke arm function in randomized trial, but 17 control patients dropping out matters

The 85-patient BCI-REHAB study found a 4.5-point treatment difference favoring IpsiHand and a number needed to treat of 2.2, although substantial control-group withdrawal complicates interpretation.

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Medical Devices & Diagnostics

Can a finger cuff replace the arm cuff? Wellvii BP Go clears a major US regulatory hurdle

FDA cleared Wellvii BP Go as a Class II non-invasive blood pressure system after published validation found its finger-based measurements met ISO 81060-2:2018 requirements.

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Medical Devices & Diagnostics

One chest CT, more signals: Coreline Soft embeds AI into St. Joseph’s lung cancer screening workflow

St. Joseph’s Health is integrating Coreline Soft’s AVIEW into its existing INFINITT PACS, allowing AI pre-analysis of lung screening CTs without sending radiologists into a separate application.

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Medical Devices & Diagnostics

Johnson & Johnson adds AI and 3D navigation to MONARCH as robotic lung biopsy race intensifies

MONARCH QUEST 3 adds AI nodule segmentation, improved registration, 3D orientation and broader cone-beam CT integration as Johnson & Johnson targets more reliable lung nodule navigation.

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Medical Devices & Diagnostics

Teoxane and Revance target undereye hollows after FDA approves RHA Redensity Eye for adults 22 and older

FDA’s PMA supplement expands RHA Redensity Eye into infraorbital volume correction, backed by a 233-patient safety population and mandatory device-specific injector training.

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Medical Devices & Diagnostics

Ambros Therapeutics takes neridronate public through Werewolf merger as $150m backs Phase 3 CRPS trial

The all-stock transaction values Ambros Therapeutics at $500 million and pairs its pivotal neridronate programme with a $150 million financing designed to fund development through Phase 3 data and an FDA filing.

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Medical Devices & Diagnostics

Cortechs.ai adds FDA-cleared PET analysis as Alzheimer’s diagnosis becomes increasingly biomarker-driven

Cortechs.ai’s NeuroQuant PET can automatically quantify amyloid PET uptake, generate SUVR and Centiloid measurements and send structured results into imaging workflows.

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Medical Devices & Diagnostics

Can resurfacing the small intestine improve type 2 diabetes? Aqua Medical’s US IDE study starts testing the idea

Aqua Medical has treated the second US patient in RESTORE-1, a 20-person IDE study evaluating whether RF vapor ablation of proximal intestinal mucosa can improve HbA1c.

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