Neuralink's "Blindsight" device, developed by Elon Musk's company, aims to restore vision for blind individuals.

The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain ...

The program gives manufacturers better access to regulators and the ability to design more flexible clinical trials.

With the FDA’s breakthrough designation, this cutting-edge technology is quickly advancing through the approval process, underscoring its potential to transform the lives of those living with ...

The device is a variant of Neuralink's brain implant technology, in this case designed to "enable even those who have lost both eyes" to see, according to owner Elon Musk. Separately, progress is ...

Neuralink, a company founded by Elon Musk in 2016, is working on brain chip interfaces aimed at addressing disabilities like ...

"We also extended our leadership in the brain-computer interface realm, adding an FDA Breakthrough Device Designation (our 10 th) and gaining admittance into the FDA's new TAP program to streamline ...

The US Food and Drug Administration (FDA) granted Abbott Breakthrough Device designation to explore use of DBS for TRD under its Breakthrough Devices Program, which expedites the review of innovative ...

Lungpacer’s AeroPace technology previously received FDA Breakthrough Device designation and during the COVID-19 pandemic had Emergency Use Authorization (EUA) for patients on MV. Without a strong ...

Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant ...

The company won US Food and Drug Administration (FDA) breakthrough device designation for the technology in February 2024, then shortly after was accepted into the FDA’s new Total Product Lifecycle ...