Bioptigen Inc., an ISO 13485-certified medical device company that develops innovative ophthalmologic imaging technologies, has received regulatory approval to market its hand-held Envisu C2000-series systems for clinical use within the European Union.
Bioptigen’s Envisu spectral domain optical coherence tomography 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 disease progression, detection and treatment.
“Earning a CE Mark is an important milestone for Bioptigen, but it’s even more meaningful for the pediatric and adult patients who now can benefit from our more flexible imaging platform. We bring imaging to the patient; the patient doesn’t have to come to us,” said Dr. Eric Buckland, president and CEO. “Knowing that Bioptigen can improve the quality of life for patients is extremely rewarding.”
Bioptigen’s Envisu C2000 series should prove especially useful for physicians treating non-ambulatory patients, as well as those suffering from conditions such as nystagmus, which causes involuntary eye movement, Buckland added.
“Physicians in Europe play a critical role when it comes to advancing non-invasive medical technologies,” Buckland said. “Bioptigen looks forward to collaborating with these professionals as they develop new best practices based on standards that benefit patients worldwide.”
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.
Availability of Envisu C-series held-hand clinical ophthalmic imaging systems in the United States 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.