MIAMI, Sept. 29, 2026 /PRNewswire/ — VertigoDx, a medical device innovator, today announced that it has received 510(k) clearance (K260566) from the U.S. Food and Drug Administration (FDA) for its SmartVertigo® Vestibular Assessment System, a prescription point-of-care platform designed to simplify the evaluation of vertigo, including Benign Paroxysmal Positional Vertigo (BPPV). SmartVertigo® combines a smartphone, proprietary light-occluding headset, and custom software to capture high-resolution, full-color video of horizontal, vertical, and torsional nystagmus during standard positional testing.
“BPPV is one of the most treatable causes of dizziness. The challenge has always been capturing the eye movement without complex equipment — and understanding what that movement is telling you,” said Dr. Paul Louis, CEO and Co-Founder of VertigoDx. “SmartVertigo® does both.”