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Medical Devices & Diagnostics

PharmaDeviceNews Medical Devices & Diagnostics
Representative image: Veracyte’s Medicare coverage win for the TrueMRD bladder cancer recurrence monitoring test highlights the growing role of blood-based molecular diagnostics in detecting muscle-invasive bladder cancer recurrence earlier and supporting more precise post-treatment surveillance.
Medical Devices & Diagnostics

Why Veracyte’s Medicare win for TrueMRD could reshape bladder cancer recurrence monitoring

MRD testing has payer momentum, but clinical adoption is tougher. Veracyte’s TrueMRD Medicare win puts bladder cancer monitoring in focus.

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Representative image: AI-powered digital pathology analysis for bladder cancer risk testing, highlighting how Valar Labs’ Vesta Bladder Risk Stratify Dx could support more precise non-muscle invasive bladder cancer prognosis after receiving FDA Breakthrough Device Designation.
Medical Devices & Diagnostics

Valar Labs FDA breakthrough nod signals new test for AI-led bladder cancer risk prediction

Bladder cancer risk tools leave gray zones. Valar Labs’ FDA breakthrough nod tests whether AI pathology can narrow them.

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Representative image: Telix Pharmaceuticals’ PSMA-PET imaging collaborations with EDAP TMS and Profound Medical highlight how advanced prostate cancer scans could support minimally invasive treatment planning, focal ablation decisions and post-treatment monitoring in next-generation urology workflows.
Medical Devices & Diagnostics

Why Telix is taking PSMA-PET deeper into minimally invasive prostate cancer treatment

Prostate ablation is getting more precise. Telix wants PSMA-PET to become the imaging layer that helps clinicians decide where to treat.

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HistoSonics seeks FDA kidney tumor authorization as Edison platform expands
Medical Devices & Diagnostics

HistoSonics is taking histotripsy beyond liver tumors. Kidney cancer care may be the next credibility test.

HistoSonics has liver clearance. Kidney tumors are the harder test, where non-invasive ambition must meet regulatory and clinical proof.

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Representative image: AI-enabled real-world evidence analysis in a diagnostics laboratory highlights how OM1’s 650,000-patient study supported FDA approval of Hologic’s Aptima HPV Assay for primary cervical cancer screening.
Medical Devices & Diagnostics

Did OM1 just prove AI-powered real-world evidence can survive FDA scrutiny?

FDA-grade evidence is getting bigger and harder to collect. OM1’s Hologic study shows how AI may change medtech submissions.

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Representative image: Aurie’s FDA De Novo grant for a reusable no-touch intermittent catheter system highlights a potential shift in urology care, as reusable catheter technology challenges the long-standing dominance of single-use urinary catheters in chronic care settings.
Medical Devices & Diagnostics

Did Aurie just crack the one-use catheter problem hospitals avoided for decades?

Single-use catheters finally face a regulated reuse challenge. Aurie’s FDA De Novo win could shift urology device economics.

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Representative image: A cuffless fingertip blood pressure monitoring device shows how Biozen’s FDA-cleared BP1000 could make calibration-free hypertension checks more accessible for home care and remote patient monitoring.
Medical Devices & Diagnostics

Can Biozen turn cuffless blood pressure from medtech promise into clinical reality?

Cuffs are accurate but inconvenient. Biozen’s FDA-cleared BP1000 tests whether fingertip blood pressure checks can change hypertension care.

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Corvention targets balloon aortic valvuloplasty gap with FDA-cleared KardiaPSI device
Medical Devices & Diagnostics

FDA clears Corvention’s KardiaPSI Balloon Catheter as structural heart tools get more specialized

Calcified aortic valves need force and control. Corvention’s KardiaPSI clearance tests whether niche BAV tools can scale clinically.

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Medical Devices & Diagnostics

How Envoy Medical, Inc.’s FDA pathway could influence the future of implantable hearing systems

Could fully implanted cochlear implants transform hearing restoration? Explore the regulatory, clinical, and market implications now.

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Representative image: A fully automated laboratory blood-testing workflow highlights how Fujirebio’s CE-marked Lumipulse G pTau 217 Plasma assay could support scalable Alzheimer’s disease diagnostics and expand access to biomarker-based cognitive decline evaluation across Europe.
Medical Devices & Diagnostics

Why Europe’s Alzheimer’s testing pathway could shift after Fujirebio’s latest CE marking

Alzheimer’s testing needs scale, not just science. Fujirebio’s CE-marked pTau 217 assay pushes blood biomarkers closer to routine care.

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