How to Classify Medical and Diagnostic Devices for European Markets
Raeesa Gupte, PhD
MDCG guidance documents help interpret classification rules for EU MDR and IVDR
Medical Implants
FDA Approves First Non-Surgical Heart Valve to Treat Congenital Heart Disease
U.S. Food and Drug Administration
New implant device provides option to treat pulmonary valve regurgitation in patients with right ventricular outflow tract
IVDR: The EU’s In Vitro Diagnostic Regulation for Medical Diagnostic Tests
Sherri Fraser, PhD
Frequently asked questions about IVDR
Breakthrough Neurotechnology for Treating Paralysis
Ecole Polytechnique Federale de Lausanne
New rehabilitation protocols lead to restored neurological function in paraplegics
Easier Treatment for Blinding Eye Disease Shows Promise in Clinical Trial
American Academy of Ophthalmology
Patients with age-related macular degeneration may soon see their monthly injection become an annual refill, with potentially better results