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Breakthrough Device Designation

Medical Devices & Diagnostics

ReCET trial enrollment puts Endogenex in focus for gut-targeted diabetes care

Endogenex has completed enrollment in the ReCET Clinical Study, a pivotal evaluation of the Endogenex System in adults with type 2 diabetes whose blood glucose levels remain inadequately controlled on non-insulin glucose-lowering medications. The study has enrolled 350 patients across approximately 40 sites in the United States and Australia, moving the clinical-stage medical device developer

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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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Medical Devices & Diagnostics

Guardant Health brings Shield multi-cancer detection test to Asia through Manulife insurer deal

Guardant Health partners with Manulife to launch its Shield MCD blood test in Hong Kong, Singapore and the Philippines. Analysis of what this means for oncology.

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Medical Devices & Diagnostics

Bioretec secures FDA Breakthrough status for RemeOs DrillPin, sharpening focus on pediatric fracture repair

Bioretec Ltd, the Finland-based medical device developer specializing in fully biodegradable orthopedic implants, has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its RemeOs DrillPin. The designation applies to the use of the biodegradable magnesium-alloy device in pediatric and adult bone fixation procedures, including epimetaphyseal fractures in children over two years

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