VertigoDx clears a smartphone nystagmus system under K260566

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via PR Newswire

FDA cleared the SmartVertigo Vestibular Assessment System under K260566 on July 30, 2026. VertigoDx, based in Miami, announced the clearance on September 30. The system records and analyzes nystagmus during standard positional testing. It uses a smartphone, a light-blocking headset and classification software.

The clearance sits under product code GWN, the nystagmograph regulation at 21 CFR 882.1460. VertigoDx filed a traditional 510(k) on February 19, 2026. The substantially equivalent decision came a little over five months later, with no third-party review. The company says its color video sensor records eye movement that infrared video-oculography misses. It puts the cost of a conventional vestibular lab at $3,000 to more than $50,000.

Co-founder Trevor Meyerowitz, a physical therapist and co-inventor, used the system on more than 1,200 patients over three years before clearance. The nystagmus classification algorithm came out of work with Florida Atlantic University. A two month gap between the decision and the press release usually means the launch set the clock, not the review.

Questions & Answers

What did FDA clear under K260566?

K260566 is the 510(k) for VertigoDx's SmartVertigo Vestibular Assessment System, found substantially equivalent on July 30, 2026. It captures and analyzes nystagmus during positional testing, including for benign paroxysmal positional vertigo.

What product code and regulation cover the VertigoDx SmartVertigo system?

SmartVertigo falls under product code GWN and 21 CFR 882.1460, the nystagmograph regulation. VertigoDx filed it as a traditional 510(k) on February 19, 2026.

How is VertigoDx SmartVertigo different from infrared video-oculography?

SmartVertigo uses a smartphone, a light-blocking headset and color video instead of an infrared camera workstation. VertigoDx says color video captures eye movement infrared misses, and it prices a conventional vestibular lab at $3,000 to more than $50,000.

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