FDA’s Breakthrough Devices Program: What It Is and How It Impacts Everyday People
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is a voluntary initiative designed to expedite the development, assessment,…
Tag: FDA APPROVED
13 FDA-Approved AI Technologies of 2024
Imagine a smart toilet that quietly analyzes your health while you go about your day, or an AI tool that…
FDA Greenlights Momentis Surgical’s Robotic Device for Hernia Repair
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Momentis Surgical for its innovative robotic surgery device, marking a…
Medical Device Company Microbot Medical Gears Up for FDA Clearance in 2025
Microbot Medical, a U.S.-based robotics company, is intensifying its go-to-market strategy in anticipation of potential FDA clearance for its LIBERTY®…
New Hope for Age-Related Macular Degeneration: FDA Clears HuidaGene’s AI-Powered CRISPR Therapy
Global biotech innovator HuidaGene Therapeutics has received FDA approval to advance with its investigational drug application for HG202, a CRISPR/Cas13…