STAT's Breakthrough Device Tracker updates: knee implant, heart …
WEB2 days ago · We identified at least 10 new breakthrough device designations between June and mid-September. Manuel Balce Ceneta/AP. By Lizzy Lawrence. Sept. 19, 2024. FDA Reporter. Check out STAT’s exclusive ...
Neuralink's 'breakthrough device' clearance from FDA does not …
WEB3 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 ...
Neuralink says the FDA designated its Blindsight implant as a ...
WEB2 days ago · Wed, Sep 18, 2024, 2:23 PM EDT · 2 min read. Reuters / Reuters. Neuralink says the Food and Drug Administration has designated its experimental Blindsight implant as a "breakthrough device." The ...
Musk's Neuralink Gets FDA's Breakthrough Device Tag for ... - U.S. News
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 ...
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...
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 …
Updated Final Guidance on Breakthrough Devices Program
WEBSep 14, 2023 · As of June 30, 2023, CDRH has granted Breakthrough Device designation to 831 devices and granted marketing authorization to 77 devices with Breakthrough Device designation.
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.
FDA Updates Final Guidance for Breakthrough Devices Program - News
WEBSep 14, 2023 · According to the agency, the 2023 update to the final guidance, Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff, clarifies: How the Breakthrough Devices Program may apply to certain medical devices that promote health equity.
The FDA’s ‘breakthrough’ medical devices are finally ... - STAT
WEBAug 11, 2022 · The Food and Drug Administration, looking to accelerate access to innovative devices, has now labeled nearly 700 products as breakthroughs while they’re under development.
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