Breakthrough Devices Program | FDA
WEBThe Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket...
Updated Final Guidance on Breakthrough Devices Program
WEBSep 14, 2023 · The 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 · Neuralink, the Elon Musk-owned brain-computer interface company, on Tuesday received “breakthrough device” clearance from the FDA. But this does not mean the outfit has developed a cure for...
Breakthrough Devices Program | FDA
WEBSep 14, 2023 · The 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...
FDA Updates Final Guidance for Breakthrough Devices Program
WEBSep 14, 2023 · How the Breakthrough Devices Program may apply to certain medical devices that promote health equity. Considerations in designating devices, including eligible devices that may support innovation of new and existing technologies that address health inequities.
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.
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.
Latest breakthrough device designations go to brain-computer …
WEBNov 22, 2021 · FDA has awarded breakthrough device designations to two futuristic devices, granting the regulatory privileges to Blackrock Neurotech’s brain-computer interface (BCI) and an exo-suit from ReWalk Robotics′ intended to …
Device experts discuss strategies for breakthrough, STeP ... - RAPS
WEBSep 26, 2022 · PHOENIX, AZ – Device manufacturers planning to submit applications through the US Food and Drug Administration (FDA)’s two novel device programs, the breakthrough devices program and Safety Technologies Programs (SteP) for Medical Devices, should consider submitting clinical data with their applications and executive summaries of how their devic...
FDA Awards Breakthrough Device Designation to the ReWalk
WEBNov 4, 2021 · Soft exoskeleton device for stroke survivors will be for use at home and in the community to help with walking and mobility. MARLBOROUGH, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- ReWalk...