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FDA clearance

Medical Devices & Diagnostics

Next-generation SIGNA MRI gains FDA nod, sharpening GE HealthCare’s imaging strategy

GE HealthCare secures FDA clearance for next-generation SIGNA MRI. Explore clinical impact, workflow gains, and market implications.

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Medical Devices & Diagnostics

Medtronic secures FDA clearance for Stealth AXiS surgical system in spine robotics

Medtronic wins FDA clearance for Stealth AXiS in spine robotics. Explore what this integrated platform means for workflow, data, and adoption.

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Medical Devices & Diagnostics

Can smart dental devices redefine sleep disorder treatment? Aesyra’s trial says yes

Aesyra’s AesyBite Active reduced sleep bruxism by over 60% in trial. Find out what this could mean for digital therapeutics and FDA approval in 2026.

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Medical Devices & Diagnostics

Aidoc secures FDA clearance for first AI triage system covering 14 acute conditions in CT

Aidoc’s CARE AI gets FDA clearance for 14-condition CT triage. Find out how it may reshape emergency imaging, hospital workflows, and clinical AI governance.

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Medical Devices & Diagnostics

Why FDA’s clearance of ACON’s Flowflex Plus test marks a turning point in home diagnostics

FDA clears Flowflex Plus 4-in-1 test for RSV, flu, and COVID in infants and adults. Find out what this means for diagnostics, families, and industry players.

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Medical Devices & Diagnostics

Vista AI raises $29.5m to expand automated MRI scanning beyond cardiology

Vista AI, a U.S.-based medical imaging software company specializing in AI-powered MRI automation, has raised $29.5 million in Series B financing to accelerate its product roadmap and scale adoption across U.S. hospitals and imaging centers. The funding round, announced on January 14, 2026, includes strategic investments from leading health systems such as Cedars-Sinai Health System,

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Medical Devices & Diagnostics

Medtronic’s MiniMed Go cleared by FDA: Can smart MDI finally close the algorithm gap in diabetes care?

Medtronic’s MiniMed Go earns FDA clearance. Learn how it could reshape insulin injection therapy by combining smart pens, CGM insights, and dose algorithms.

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Medical Devices & Diagnostics

Can Avatar Medical’s glasses-free 3D imaging shift patient communication from confusion to clarity?

Avatar Medical is set to introduce Eonis Vision, a glasses-free 3D medical imaging system, at CES 2026. The product, developed in collaboration with Belgian display specialist Barco and powered by high-performance Dell hardware, is aimed at enhancing the clarity of doctor–patient communication. While the original Avatar Medical Vision software is already FDA-cleared, the updated version

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Features & Analysis

Is dental bone glue the new frontier in graft-free implantology? What RevBio’s TETRANITE trial could mean for chairside workflows

RevBio Inc. has received approval from the United States Food and Drug Administration to initiate a pilot clinical trial evaluating TETRANITE, its regenerative bone adhesive, for dental ridge augmentation procedures. The trial will examine whether the product can eliminate the need for membranes, meshes, tacks, and fixation screws—elements that have traditionally been considered essential for

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Medical Devices & Diagnostics

Kallisio’s Stentra system enters clinical use at Stanford, expanding precision radiation toolkit for head and neck cancer

Kallisio has begun clinical implementation of its FDA-cleared Stentra system at Stanford Health Care, marking the first reported integration of the patient-specific intraoral device into a major U.S. hospital’s workflow for head and neck cancer radiation therapy. The system, which received 510(k) clearance in January 2024, enables individualized immobilization of oral structures during intensity-modulated radiation

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