Bioptigen Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) devices for patient use.
The Envisu SDOIS aids in the diagnosis of physiological and pathological conditions of the eye through non-contact optical imaging. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography imaging systems commercially available in the United States for hand-held and pediatric imaging.
Envisu’s ergonomic, hand-held scanner enables imaging of patients of all ages – from premature and neonatal infants to adults – whether they are upright or supine, ambulatory or confined. And interchangeable lenses allow clinicians to image various structures of the eye, from cornea to retina.
“Our devices are generally indicated for patients who are not well suited to imaging with traditional, tabletop devices,” said Dr. Eric Buckland, president and CEO of Bioptigen. “Bioptigen’s Envisu ophthalmic imaging devices provide a unique degree of flexibility that benefits clinicians and the patients they care for. It’s exciting to be able to market our C-series devices in the United States and support efforts by health-care providers to deliver appropriate medical interventions, especially for the underserved pediatric patient population.”
Bioptigen already has received regulatory approval from Canadian, European and Australian authorities to commercially market its Envisu C2200 and C2300 ophthalmic imaging devices in those respective regions.
The National Institutes of Health recently awarded Bioptigen a grant to continue investigation of ophthalmic imaging solutions for premature and neonatal infants.
Deployed in the top 10 U.S. ophthalmic research institutions, Bioptigen (bioptigen.com) devices are covered by 60-plus patent applications, including 30 awarded patents. More than 100 scientific articles have been published citing data acquired with Bioptigen technologies.