VertigoDx today announced that it has received 510(k) clearance from the 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).
It 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.
Vertigo can be challenging to evaluate in acute and outpatient settings. BPPV is caused by tiny calcium crystals that dislodge within the semicircular canals, triggering nystagmus—involuntary eye movements—that clinicians must capture to make an objective diagnosis. Traditional infrared video-oculography (VOG) systems are often expensive, complex and tethered to dedicated workstations, leaving many clinicians without portable, objective diagnostic tools—resulting in care delays, unnecessary imaging, and avoidable specialist referrals.
SmartVertigo helps replace bulky infrared systems with a portable, cable-free unit. Unlike traditional infrared VOG, which produces black-and-white video, SmartVertigo captures full-color eye movement video. Color may reveal subtle findings—vessel movement—that infrared video cannot show. Clinicians can replay video in real time, slow motion, or frame-by-frame to confirm findings.
