Home Tags FDA approval

FDA approval

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...
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)...
Monarch eTNS System

FDA Approves Breakthrough Medical Device for Children with ADHD

The US federal regulators have OK’d the first medical device to treat children with attention deficit hyperactivity disorder (ADHD).The US Food and Drug Administration...
Optimizer Smart System for CCM Therapy

Impulse Dynamics receives FDA approval for the First Ever Optimizer Smart System for Delivering...

Pacemakers are designed to monitor and record the rate and rhythm of the heart and make sure the heart rate doesn’t get too...
BIOTRONIK Tachycardia device

BIOTRONIK Receives FDA Approval for Six Tachycardia Devices

Cardiac patients have varying conditions, so physicians need more comprehensive therapy options when treating these patients. BIOTRONIK, a Berlin, Germany-based biomedical technology company, just...
OSSIOfiber Implant System

OSSIO Developing Absorbable Fixation Devices that Promotes Bone Growth and Removes Need for Surgery

Metal implants can cause unwanted removal surgeries, associated complications and an unnatural healing environment for patients. OSSIOfiber, developed by an orthopedic fixation company called...