Tag: FDA approval
Google Seeks FDA Nod For Fitbit’s Passive Heart Rate Monitoring Tech
Fitbit’s parent company Google is seeking US Food and Drug Administration (FDA) approval for Fitbit's passive heart rate monitoring algorithm.
Related Fitbit Wearables Will Soon...
Theranica Wins FDA Approval for Its Wearable Nerivio to Treat Acute Migraine in Adolescents
Theranica, a prescribed digital therapeutics (PDT) company developing advanced electroceuticals for migraine and other pain conditions, announced that its Nerivio therapeutic device has received...
Abbott Receives FDA Approval for Gallant Heart Rhythm Implants Featuring Continuous Remote Monitoring
Abbott won FDA approval for its next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. Cleared in Europe earlier this...
Zeto Raises $7.3M in Series A Funding for EEG Headset and Software Platform
Zeto, a Santa Clara, CA-based medical technology company that is focused on transforming the way electroencephalography (EEG) is performed at hospitals and clinics, announced...
Medtronic Files for FDA Approval of Its InterStim Micro Neurostimulator
Medtronic has filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator and the accompanying InterStim SureScan MRI...
ABBOTT’s Proclaim XR Spinal Cord Stimulator Gets FDA Approval for Chronic Pain Management
Abbott won FDA approval for its Proclaim XR recharge-free neurostimulation system for people living with chronic pain. The neurostimulator can treat chronic pain for...