A noninvasive eye imaging system developed by medical device company Bioptigen now has regulatory clearance for use on patients in the United States. Bioptigen received 510(k) clearance from the U.S. Food and Drug Administration for its hand-held Envisu Spectral Domain Ophthalmic Imaging System. Bioptigen’s devices use a technology called optical coherence tomography. The company’s noninvasive […]
Medical device company Bioptigen has received a $2.7 million federal grant that will be used to research applications of its optical imaging technology in pediatrics. The 27-month grant comes from the National Eye Institute of the National Institutes of Health. Research Triangle Park, North Carolina-based Bioptigen has developed and brought to market an ophthalmic imaging […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Medical device company Bioptigen is developing its medical imaging technology into a new device for eye surgeries and the North Carolina firm has found two partners to join the effort. Bioptigen will combine its imaging technology with research from Irvine, California-based Adventus Technology and The Brien Holden Vision Institute, an Australian nonprofit group that works […]
Medical imaging technology company Bioptigen, based in Research Triangle Park, North Carolina, has received a warning that its hand-held imaging device for the eye is being marketed beyond the scope of its 510(k) clearance.
Case Western Reserve University and University Hospitals Case Medical Center have licensed medical imaging technology called optical coherence tomography (OCT) to Bioptigen Inc. in Research Triangle Park, N.C. Bioptigen plans to use the technology to help the early diagnosis of eye diseases.