The FDA has granted 510(k) clearance to Miami-based VertigoDx for its portable diagnostic system that can evaluate vertigo, including benign paroxysmal positional vertigo (BPVV).
Dubbed SmartVertigo vestibular assessment system, the device combines a smartphone, a headset that blocks light and software that tracks rapid and involuntary eye movement to determine if a patient’s vertigo or dizziness is caused by an inner ear issues such as BPVV or from a central nervous system disorder.
BPPV is triggered by calcium crystals that break away in the semicircular canals, which cause nystagmus—involuntary eye movements—which clinicians must capture to make an objective diagnosis, the company said.
“BPPV is one of the most treatable causes of dizziness,” Paul Louis, VertigoDx co-founder and CEO, said in a statement. “The challenge has always been capturing the eye movement without complex equipment—and understanding what that movement is telling you. It does both.”
The system, which has been used on more than 1,200 patients in the past three years, replaces traditional infrared, black and white video-oculography workstations and specialist referrals with color video that detects more subtle findings that infrared can’t show.
SmartVertigo is a prescription point-of-care platform developed by brothers Trevor and Stephen Meyerowitz who are VergioDx’s CMO and CTO, respectively.
“Some eye movements are too subtle to catch with standard Frenzel goggles,” Trevor Meyerowitz, said. “Now I can replay the video and capture the nystagmus data I need. Using AI and the SmartVertigo algorithms gives me greater diagnostic confidence—and showing patients their nystagmus means we both know what we're treating.”
Back in 2021, Mark Cuban-backed Otolith Labs earned FDA breakthrough device designation for its noninvasive Vestibular System Masking (nVSM) technology to treat the symptoms of chronic vertigo.