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Neuralink says FDA designated its Blindsight implant

Neuralink's 'breakthrough device' clearance from FDA does not mean it has cured blindness

Neuralink, the Elon Musk-owned brain-computer interface company, has received "breakthrough device" clearance from the FDA. The breakthrough devices program at the FDA is a voluntary program that developers can apply to that,

PC Gamer on MSN · 3d

Elon Musk goes all Star Trek as his sight-giving Blindsight brain implant gets FDA 'breakthrough' clearance

Elon Musk's Blindsight brain implant has achieved a major milestone. It's now being worn by Geordi La Forge. No wait, it's actually been awarded Breakthrough Device Designation by the FDA. But to celebrate, Musk evoked the famously vision-enhanced Star Trek character in an X post.

Engadget on MSN · 3d

Neuralink says the FDA designated its Blindsight implant as a 'breakthrough device'

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.

These Apple Devices Are Now FDA-Approved

Over the past week, the FDA cleared two of Apple's new health features: The agency approved AirPods Pro 2's new hearing-aid ...

MassDevice2d

Alesi Surgical wins FDA clearance for smoke management device and lands new funding

Alesi Surgical designed the Ultravision2 IonPencil for cutting and coagulating soft tissue in open surgery while managing ...

drugdeliverybusiness4d

Senseonics wins FDA nod for 365-day implantable CGM

Senseonics (NYSE:SENS) announced today that it received FDA clearance for its next-generation Eversense 365 CGM system.

FierceBiotech3d

GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease

GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density ...

GlobalData on MSN3d

GE HealthCare’s MIM Software scoops FDA clearance on Alzheimer’s diagnostic

MIM Software has secured 510(k) clearance from the US Food and Drug Administration (FDA) to offer its MIMneuro software with ...

7don MSN

DeepWell DTx receives FDA clearance for its therapeutic video game developer tools

There’s something oddly refreshing about starting the day by solving the Wordle. According to DeepWell DTx, there’s a ...

11d

DeepWell gets FDA clearance for games and interactive media to treat mental health issues

DeepWell said it has received a groundbreaking clearance from the FDA for games and interactive media to treat mental health ...

GlobalData on MSN4d

Epitomee Medical receives FDA clearance for weight management capsule

Epitomee Medical has received approval from the US Food and Drug Administration (FDA) for the Epitomee Capsule, an ingestible ...

Monthly Prescribing Reference4d

Long-Term CGM System Eversense 365 Gets FDA Clearance

Eversense 365 is a fully-implantable CGM with a 365-day sensor, making it the first 1-year CGM option for diabetes management ...

Avicenna.AI lands FDA clearance for AI tool that detects cervical spine fracture

Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-CSpine tool. Using a combination of deep learning and ...

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