Neuralink says the Food and Drug Administration has designated its experimental Blindsight implant as a "breakthrough device." The company is developing the technology in an attempt to restore blind people's sight. Manufacturers who apply to the FDA's voluntary breakthrough devices program and receive the designation from the agency are granted "an opportunity to interact with FDA experts through several different program options to efficiently address topics as they arise during the premarket review phase." Ultimately, a breakthrough device designation can accelerate development of a technology. Last year, the FDA gave the designation to 145 medical devices.

Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S. Food and Drug Administration's "breakthrough device" designation. 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 the development and review of devices currently under development. The experimental device, known as Blindsight, "will enable even those who have lost both eyes and their optic nerve to see," Musk said in a post on X. Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for comment.

An artificial intelligence algorithm developed by Rochester, Minn.-based Mayo Clinic and cardiac monitoring startup Eko to analyze ECG data for evidence of reduced left ventricular ejection fraction has been designated a "breakthrough device" by the FDA. The algorithm reads ECG data collected by Eko's digital stethoscope to measure LVEF, which refers to the amount of blood pumped out of the heart's left ventricle and can indicate heart failure. The breakthrough device label, presented to technology with potential to address unmet clinical needs, will speed up regulatory review of the algorithm. Eko and Mayo Clinic's partnership to develop the AI algorithm began in late 2018. Since then, studies have shown that the algorithm-equipped stethoscope achieves significant accuracy in detecting low ejection fraction.

Since the beginning of the month, the FDA has granted several artificial intelligence-powered health IT products "Breakthrough Device" status, which does not indicate safety approval, but designates a product as potentially life-saving and fast-tracks its development, testing and approval process.