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Medical Devices & Diagnostics

Medical Devices & Diagnostics

Insight Molecular Diagnostics builds regulatory case for GraftAssureDx kidney transplant test

Insight Molecular Diagnostics advances GraftAssureDx toward FDA submission. Discover what this means for transplant rejection testing and dd-cfDNA diagnostics.

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Medical Devices & Diagnostics

What FDA clearance means for Median Technologies eyonis LCS in a crowded AI radiology market

Median Technologies advances eyonis LCS after FDA clearance. Discover what this means for AI lung cancer screening and European expansion.

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Medical Devices & Diagnostics

Lucent Diagnostics expands cognitive biomarker reach through Life Line Screening

Lucent Diagnostics partners with Life Line Screening to expand Alzheimer’s blood testing nationwide. Discover what this means for early detection.

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Medical Devices & Diagnostics

Faster Candida auris identification? Thermo Fisher Scientific unveils new agar

Thermo Fisher Scientific launches chromogenic media to detect Candida auris faster. Explore what this means for labs and AMR strategy.

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Medical Devices & Diagnostics

LRS wins FDA clearance to test ThermoSuit cooling device in pivotal ischemic stroke trial

Life Recovery Systems (LRS), a medical device developer headquartered in Alexandria, Louisiana, has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to advance its ThermoSuit System into a pivotal clinical trial enrolling ischemic stroke patients. The study, which will enroll up to 160 patients across as many as eight hospitals,

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Medical Devices & Diagnostics

Can OSSIOfiber metal free bunion fixation redefine minimally invasive hallux valgus surgery?

Ossio Inc. launches OSSIOfiber MIA bunion system. Explore what this means for metal free fixation and orthopedic surgery adoption trends.

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Medical Devices & Diagnostics

Organon & Co. strengthens LARC strategy with MIUDELLA license from Sebela Pharmaceuticals

Organon & Co. licenses MIUDELLA copper IUD. Explore what this means for hormone-free contraception and LARC competition. Read the analysis.

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Medical Devices & Diagnostics

Biomerica’s responder data raises new questions about diet-driven IBS management

Biomerica reports real-world IBS responder data and Medicare coverage. Explore what this means for adoption, reimbursement, and competition.

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Medical Devices & Diagnostics

Can ClearNote Health’s Avantect test finally close the early detection gap in pancreatic cancer

ClearNote Health’s updated Avantect test improves pancreatic cancer detection in high-risk patients. Find out what this changes for early screening strategies.

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Medical Devices & Diagnostics

What Bristol Myers Squibb’s luspatercept results reveal about the future of alpha thalassemia care

Bristol Myers Squibb reports positive luspatercept data in alpha thalassemia. Find out what this could change for treatment and regulation.

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