Home Tags FDA approval

Tag: FDA approval

Abbott FDA Approval Gallant Heart Rhythm Implants

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 year, the implants feature Bluetooth connectivity, […]
Zeto zEEG headset

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 that it has raised $7.3 million […]
Medtronic InterStim Micro neurostimulator

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 leads. The device is used to […]
Abbott proclaim xr

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 up to ten years without requiring […]
SYNCHRONY cochlear implants

FDA Approves First Cochlear Implants for Single-Sided Deafness and Asymmetric Hearing Loss

MED-EL USA announced that its SYNCHRONY and SYNCHRONY 2 cochlear implants have won the first FDA approval for people with single-sided deafness (SSD) and those with asymmetric hearing loss (AHL). […]
Eversense Implantable CGM System

Senseonics Gets FDA Approval for Eversense Implantable CGM System

Senseonics, a company that develops implantable continuous glucose monitoring (CGM) system for people with diabetes, received FDA approval for the non-adjunctive indication (dosing claim) for its Eversense CGM. Related Nemaura’s […]