FDA Grants Breakthrough Status to Devices Targeting Alzheimer's, Heart Failure, and More
• The FDA granted breakthrough device designation to Boston Scientific's Vercise deep brain stimulation (DBS) system for mild probable Alzheimer's in patients 65 and older.
• Cognito Therapeutics received breakthrough designation for its neurostimulation device, designed to reactivate the brain's immune system by stimulating it at a specific frequency.
• Puzzle Medical Devices' ModulHeart, a minimally invasive transcatheter heart pump, received breakthrough status, offering a potential alternative to open-heart surgery for heart failure patients.
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