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United States Food and Drug Administration

Medical Devices & Diagnostics

How AnX Robotica’s NaviCONNECT platform could change capsule endoscopy practice management

AnX Robotica launches NaviCONNECT to bring NaviCam capsule studies, AI-assisted review and multi-site workflows into a secure cloud platform.

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Pharma & Biotech

argenx Forte Biosciences acquisition: What the $2.2bn FB102 deal means for immunology

argenx is buying Forte Biosciences for $2.2bn to secure FB102. See why early vitiligo and celiac data make Phase 2 execution decisive.

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Medical Devices & Diagnostics

Brandage targets children’s first-aid market with tattoo-transfer bandage design

Brandage takes tattoo-transfer adhesive bandages to ASD Market Week, testing whether playful wound care can win national retail distribution.

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Medical Devices & Diagnostics

ALZpath just gave Alamar a bigger Alzheimer’s diagnostics role, but the regulatory test starts now

ALZpath expands its Alamar Biosciences deal into clinical diagnostics, opening a new path for pTau217 blood tests in Alzheimer’s disease.

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Medical Devices & Diagnostics

Momentis Surgical Anovo FDA clearance expands robotic surgery to multiport procedures

Momentis Surgical wins FDA clearance for Anovo multiport surgery, widening its robotic platform while adoption and evidence remain key.

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Pharma & Biotech

AnHorn Medicines doses first participant in Phase 1 AH-008 CIPN prevention trial

AnHorn Medicines doses the first participant in a Phase 1 AH-008 study, opening a cautious clinical test of chemotherapy neuropathy prevention.

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Pharma & Biotech

Novellia’s GLP-1 registry found a surprising weight-loss pattern, but what does it really prove?

See how Novellia’s GLP-1 registry could sharpen real-world evidence while facing tests on validation, bias, privacy and payer use.

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Medical Devices & Diagnostics

Fapon’s ADLM 2026 showcase looks bigger than a product launch. Here is the real diagnostics strategy

Fapon unveils AI-engineered PCR enzymes and Alzheimer’s biomarker reagents at ADLM 2026, targeting faster North American IVD development.

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Medical Devices & Diagnostics

SurGenTec’s ION-L can now connect with StealthStation, but will navigation unlock hospital adoption?

SurGenTec’s ION-L gains FDA-cleared StealthStation navigation compatibility, but adoption will depend on clinical proof and operating-room economics.

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Medical Devices & Diagnostics

EndoQuest’s ELS robot posted striking early resection results. What will the FDA demand next?

EndoQuest completes PARADIGM enrollment with encouraging preliminary ESD results, setting up a critical FDA De Novo submission.

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