Bionic Vision Lab @bionicvisionlab.org · Oct 3 1 / 3
Michelle Sandrian (@US_FDA) gives an update about investigational device exemption (IDE) & humanitarian device exemption (HDE). She highlights expectations & common review areas of concern for retinal implant apps & asks for standardization of visual outcome measures #TEATC2021
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Jessy Dorn ($EYES) reporting on adverse events and vision outcomes from the Orion clinical trial: - 1 adverse event so far - 4/6 participants remain in the study w/ good safety profile - visual outcomes similar to Argus II