Tag: FDA approval
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...
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)...
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...
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 slow. An...
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 received FDA...
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 OSSIO, is...