Healio

‘A bridge to transplant’: Implantable dialysis device receives FDA breakthrough status

In December, the FDA granted breakthrough status for an implantable kidney replacement system for patients with end-stage ...
Yahoo

Elon Musk’s Neuralink brain chip receives FDA’s ‘breakthrough device’ status — and could help blind people see again

Neuralink's Blindsight implant received a special status from the FDA. Elon Musk’s brain chip firm Neuralink has received “breakthrough device” status for an implant aimed at helping blind patients ...
Healio

FDA grants device for treatment of chronic limb-threatening ischemia breakthrough status

Please provide your email address to receive an email when new articles are posted on . The FDA granted breakthrough device status to a novel system for the treatment of chronic limb-threatening ...
Business Wire

FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platform

Toku’s AI (CLAiR) technology platform has received FDA Breakthrough Device status, and if cleared by the FDA will deliver real-time cardiovascular disease (CVD) risk assessments through routine eye ...
Land Line

Recently revoked ELD regains approved status

Electronic logging devices can be added back to the approved list if “the ELD provider corrects all identified deficiencies”. However, the agency said it “strongly encourages” carriers to be proactive ...