Bioptigen has received 510(k) clearance from the FDA to begin marketing its hand-held spectral-domain optical coherence tomography (OCT) device (Envisu) for use in patients.
Durham, NC-Bioptigen has received 510(k) clearance from the FDA to begin marketing its hand-held spectral-domain optical coherence tomography (OCT) device (Envisu) for use in patients.
The device uses non-contact optical imaging to assist in diagnosing physiologic and pathologic conditions of the eye. According to the company, it is the first OCT imaging system to be commercially available in the United States for hand-held and pediatric imaging.
“Our devices are generally indicated for patients who are not well-suited to imaging with traditional, tabletop devices,” said Eric Buckland, PhD, president and chief executive officer of Bioptigen. The hand-held scanner permits imaging of patients of all ages, whether they are upright or supine, ambulatory or confined. And interchangeable lenses allow clinicians to capture images of various structures of the eye, from cornea to retina.
The company previously received regulatory approval from Canadian, European, and Australian authorities to market two models (Envisu C2200 and C2300) of ophthalmic imaging devices commercially in those respective regions.
The National Institutes of Health recently awarded the company a grant to continue investigating the use of ophthalmic imaging in premature and neonatal infants.
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