Hand-held optical coherence tomography device cleared for marketing

Key Points

Research Triangle Park, NC-The FDA has cleared for marketing a hand-held spectral-domain ophthalmic imaging system (Envisu, Bioptigen) that opens new doors to ophthalmologists to diagnose eye disease in infants, children, and disabled adults.

Last month's 510(k) clearance of the device makes it the first optical coherence tomography (OCT) imaging system to be commercially available in the United States for hand-held and pediatric imaging, the company said in a prepared statement.

The system will allow pediatric ophthalmologists to diagnose retinal disease, examine the nerve fiber layer, and assess the cornea, sclera, and conjunctiva. It also is the first device cleared for imaging under anesthesia, said Eric Buckland, PhD, Bioptigen president and chief executive officer.

Although OCT has existed for 15 years, pediatric ophthalmologists have not been able to take advantage of the imaging technology because devices required young or disabled patients to sit up to a tabletop device and cooperate with clinicians.