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Medical Devices & Diagnostics

PharmaDeviceNews Medical Devices & Diagnostics
Representative image of a modern pathology laboratory where automated PD-L1 cancer diagnostic testing is supporting faster immuno-oncology treatment decisions, reflecting Agilent Technologies’ expanded FDA approval for PD-L1 IHC 22C3 pharmDx on the Dako Omnis platform.
Medical Devices & Diagnostics

Agilent wins FDA backing to move more Keytruda-linked PD-L1 testing onto Dako Omnis

Find out how Agilent’s expanded PD-L1 test approval could change automated cancer diagnostics and oncology lab workflows.

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Reach Surgical’s Sound Reach Swift gains CE Mark as demand rises for precision surgical tools
Medical Devices & Diagnostics

Genesis MedTech targets open surgery efficiency with Sound Reach Swift CE Mark approval

Find out how Reach Surgical’s Sound Reach Swift CE Mark approval could reshape open surgery energy device workflows in Europe.

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Representative image of clinicians reviewing genomic cancer testing data and medical imaging, reflecting Veracyte’s Prosigna and Decipher ASCO 2026 results and the growing role of precision oncology diagnostics in breast cancer and prostate cancer treatment decisions.
Medical Devices & Diagnostics

Can Veracyte’s Prosigna data change chemotherapy decisions in high-risk breast cancer?

Veracyte’s ASCO data could reshape chemotherapy decisions in breast and prostate cancer. Find out why genomic testing is gaining ground.

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Representative image of an oncologist reviewing melanoma imaging and molecular cancer data, reflecting Natera’s Signatera collaboration with Diakonos Oncology and the growing role of ctDNA monitoring in refractory melanoma immunotherapy trials.
Medical Devices & Diagnostics

Why Natera’s Diakonos Oncology collaboration matters for ctDNA-guided cancer drug development

Natera’s Signatera will track molecular response in a refractory melanoma trial. Find out why ctDNA is becoming central to oncology R&D.

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Representative image of a medical aesthetics consultation, reflecting Aphranel MagiCCrystal CaHA Filler’s EU MDR certification and the growing role of regenerative injectable treatments in Europe’s premium dermal filler market.
Medical Devices & Diagnostics

Why Aphranel’s EU MDR approval could sharpen competition in CaHA dermal fillers

Aphranel’s CaHA filler has secured EU MDR certification. Find out what this means for regenerative aesthetics and Europe’s filler market.

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Representative image showing AI-driven oncology research and cancer data analysis, reflecting Tempus AI’s Lens expansion into agentic AI tools for precision medicine and biopharma drug development.
Medical Devices & Diagnostics

Why Tempus AI’s Lens upgrade matters for precision oncology drug development

Tempus AI expands Lens with agentic AI for oncology drug development. Find out how it could reshape trials, evidence generation and biopharma R&D.

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Medical Devices & Diagnostics

Can Veracyte’s Decipher Prostate test change who gets chemotherapy in metastatic prostate cancer?

Can Veracyte’s Decipher Prostate test change chemotherapy decisions in metastatic prostate cancer? Find out what ENZAMET data means today.

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Representative image of a medical-grade hyperbaric oxygen therapy chamber in a clinical setting, reflecting MD Hyperbaric’s expansion into Texas, Nevada and New York as demand grows for HBOT, recovery medicine and outpatient healing services.
Medical Devices & Diagnostics

Can MD Hyperbaric turn medical-grade HBOT into a mainstream recovery clinic model?

HBOT demand is rising beyond hospitals. MD Hyperbaric’s clinic expansion tests whether recovery care can scale without losing clinical rigor.

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Representative image of AI-powered digital pathology being used to analyse prostate cancer biopsy slides, reflecting Acupath Laboratories’ integration of the ArteraAI Prostate Test into its diagnostic workflow for localized prostate cancer risk stratification.
Medical Devices & Diagnostics

What Acupath’s ArteraAI Prostate Test rollout reveals about the next phase of precision oncology

Acupath adds ArteraAI Prostate Test to its pathology workflow. Find out what it means for AI prostate cancer risk stratification today.

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Representative image of AI-driven heart failure monitoring at home, showing how Coredio’s FDA breakthrough-designated platform could extend advanced cardiac assessment beyond hospital settings through wearables, blood pressure cuffs, and remote clinical review.
Medical Devices & Diagnostics

FDA breakthrough status gives Coredio’s AI heart failure platform a faster regulatory path

Coredio’s AI heart failure platform may bring hemodynamic insight into home care. See why FDA breakthrough status matters now.

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