Bioptigen, Inc. has received a medical device license from Health Canada to begin marketing its hand-held Envisu SDOIS C2200 and C2300 ophthalmic imaging systems for patient use.
Bioptigen’s Envisu C series SDOIS imaging systems use low-power, near-infrared light to generate real-time, high-resolution, depth-resolved images of eye structures, equipping researchers and clinicians to explore new avenues of understanding in eye disease progression, detection and treatment.
“Now that Bioptigen has regulatory approval to market our technology in Canada and the European Union, adults and children can begin benefitting from this flexible and detailed imaging platform that complements existing diagnostic techniques and treatments,” said Dr. Eric Buckland, president and CEO.
With its unique hand-held scanner, Bioptigen’s Envisu C series SDOIS is particularly useful for pediatric and non-ambulatory patients, Buckland added.
Availability of Envisu systems in the United States for patient use is dependent upon review and market clearance by the U.S. Food and Drug Administration.
The National Institutes of Health recently awarded Bioptigen a grant to investigate a compact, hand-held device for use with premature and neonatal infants.
Deployed in the top 10 U.S. ophthalmic research institutions, Bioptigen 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.