Bioptigen’s Envisu™ Becomes First OCT System FDA Cleared For Hand-held Paediatric Ophthalmic Imaging

In short

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.


The Envisu SDOIS aids in the diagnosis of physiological and pathological conditions of the eye through non-contact optical imaging. The product’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. Interchangeable lenses allow clinicians to image various structures of the eye, from cornea to retina.

The (US) National Institutes of Health recently awarded Bioptigen a grant to continue investigation of ophthalmic imaging solutions for premature and neonatal infants.

Company comments

“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 paediatric patient population.”

Regulatory status

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.

Source: Bioptigen Inc.