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https://www.medtechdive.com/news/cms-proposes-repeal-of-add-on-payment-path-for-breakthrough-devices/817829/
CMS proposes repeal of add-on payment path for breakthrough devices | MedTech Dive
The Centers for Medicare and Medicaid Services said it developed concerns about the limited evaluation process for the devices after gaining experience with...
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https://www.medicaldesignandoutsourcing.com/fda-cms-rapid-new-medicare-coverage-pathway-breakthrough-devices/
FDA, CMS unveil RAPID Medicare coverage pathway for breakthrough devices
Apr 23, 2026 - RAPID could enable Medicare coverage and payment as soon as two months after FDA approval, compared to a year or more with current pathways.
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https://www.statnews.com/2025/03/27/fda-breakthrough-device-tracker-updated-with-alzheimers-blood-tests-new-ai-chatbot/
FDA breakthrough devices include new blood tests for Alzheimer's
Mar 27, 2025 - STAT Breakthrough Device Tracker update includes blood tests for Alzheimer's and an AI chatbot that can digest images and discuss the results with a doctor.
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https://www.healthcaredive.com/news/cms-fda-unveil-speedier-medicare-coverage-pathway-for-breakthrough-devices/818328/
CMS, FDA unveil speedier Medicare coverage pathway for breakthrough devices | Healthcare Dive
The pathway is designed to reduce the delay between FDA authorization and Medicare coverage for certain Class II and Class III breakthrough medical devices.
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https://www.healthcaredive.com/news/cms-proposes-repeal-of-add-on-payment-path-for-breakthrough-devices/817834/
CMS proposes repeal of add-on payment path for breakthrough devices | Healthcare Dive
The agency said it developed concerns about the limited evaluation process for the devices after gaining experience with the alternative pathway.
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https://www.statnews.com/2026/01/14/medicare-automatic-coverage-medical-devices-fda-deems-breakthrough/
How much Medicare stands to pay for FDA breakthrough devices | STAT
As Congress considers automatic Medicare coverage for 'breakthrough' devices, experts caution that it could drive up costs without improving patient outcomes.
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https://www.azooptics.com/News.aspx?newsID=30661
Scientists Turn “Mess” into Breakthrough: Chaotic Design Unlocks Next-Generation Optical Devices
Researchers from the Monash University School of Physics and Astronomy have flipped a long-held assumption in optics, showing that deliberately introducing...
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https://www.techtarget.com/healthcarepayers/news/366642432/CMS-accelerates-Medicare-coverage-for-breakthrough-medical-devices
CMS accelerates Medicare coverage for breakthrough medical devices | TechTarget
The agency and FDA announced a new Medicare coverage pathway for certain breakthrough medical devices that cuts the reimbursement timeline from 1+ years to...
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