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Medical Devices & Diagnostics

Medical Devices & Diagnostics

Why E-Scopics’ new Hepatoscope clearance could reshape point-of-care liver diagnostics

Liver diagnostics need speed and scale. E-Scopics’ Hepatoscope clearance tests whether bedside elastography can move deeper into routine care.

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Medical Devices & Diagnostics

How Agendia’s breast cancer assays are testing the limits of race-based clinical assumptions

Race matters in care access, but tumor biology may drive response. Agendia’s FLEX data sharpen the breast cancer equity debate.

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Medical Devices & Diagnostics

Why TaeWoong Medical USA’s SPAXUS clearance could sharpen the race in therapeutic EUS

Therapeutic EUS is getting more competitive. TaeWoong Medical USA’s SPAXUS clearance now faces the harder test: real-world adoption.

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Medical Devices & Diagnostics

Could Capitan Orthopedics’ SupraSpacer reshape irreparable rotator cuff tear treatment?

Rotator cuff care has a treatment gap. Capitan Orthopedics’ SupraSpacer now has FDA breakthrough status, but evidence will decide adoption.

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Medical Devices & Diagnostics

FDA clears Theradaptive’s OASIS pivotal trial as spinal fusion graft race enters a new phase

Spine biologics has long lacked fresh competition. Theradaptive’s OsteoAdapt SP trial could test whether that market is ready to move.

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Medical Devices & Diagnostics

Can ZETA SURGICAL turn brain biopsy and hydrocephalus procedures into point-of-care care?

Neurosurgery needs precision beyond elite hospitals. ZETA SURGICAL’s FDA clearance puts AI-guided access to the real-world test.

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Medical Devices & Diagnostics

Why 3Shape’s Dx Software clearance matters for digital dentistry’s next phase

Dental AI is moving from scan capture to diagnosis support. 3Shape Dx now faces the harder test of U.S. clinician adoption.

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Medical Devices & Diagnostics

FDA clears Olympus POWERSEAL Open Extended Jaw as surgical energy competition grows

Olympus cleared a new POWERSEAL device, but adoption now depends on surgeon trust, hospital value reviews, and open surgery workflow gains.

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Medical Devices & Diagnostics

Why PreludeDx’s second FDA breakthrough device designation matters for precision diagnostics

Breast cancer care needs sharper radiation decisions. PreludeDx’s AidaBREAST now faces the harder test of validation, adoption and access.

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Medical Devices & Diagnostics

What Orchestra BioMed Holdings, Inc.’s AVIM strategy reveals about the future of hypertension device innovation

FDA backing boosts AVIM therapy momentum. Discover how Orchestra BioMed Holdings, Inc. is shaping the future of hypertension treatment.

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