Breakthrough Devices Program | FDA
WEBThe Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of...
Neuralink's 'breakthrough device' clearance from FDA does not …
WEB4 days ago · The breakthrough devices program at the FDA is a voluntary program that developers can apply to that, if granted, “offers manufacturers an opportunity to interact with FDA experts through ...
FDA grants new heart failure implant its breakthrough device …
WEBJul 22, 2024 · Restore Medical, an Israeli healthcare technology company focused on developing heart failure therapies, has received the FDA’s breakthrough device designation for its new ContraBand device. The designation specifically covers heart failure with reduced ejection fraction (HFrEF) patients …
FDA approves new device for treating moderate to severe chronic …
WEBThe FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate...
Musk's Neuralink gets FDA's breakthrough device tag for …
WEB4 days ago · The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices ...
Roche granted FDA Breakthrough Device Designation for blood
WEBBasel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
FDA Updates Breakthrough Devices Program Guidance
WEBSep 20, 2023 · The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
WEBOct 28, 2022 · The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products (/combination-products/about-combination-products) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Karius wins FDA breakthrough device designation for lung …
WEBMay 16, 2024 · Fresh after securing $100m in financing earlier this month, Karius has a regulatory win after the US Food and Drug Administration (FDA) granted breakthrough device designation to its DNA-based blood test for lung infections in …
FDA Breakthrough Devices Program nears 300 designations
WEBMay 27, 2020 · At least six medtech companies have announced breakthrough device designations in recent weeks for potential new treatments addressing ventricular tachycardia and damage to the aortic arch, to multiple sclerosis and Parkinson's disease. Here's a snapshot of the products.
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