Devices & Diagnostics

Hand-held eye imaging device from Bioptigen gets 510(k) clearance

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 […]

Devices & Diagnostics

Medical device firm Bioptigen lands $2.7M SBIR grant

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 […]


N.C. medical device firm Bioptigen finds partners for new eye device

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 […]