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The Future Of Vision And Eye Care

The Medical Futurist

The 80-year-old Ray Flynn lost his central vision entirely, but with the help of the retinal implant, he could make out shapes on the computer screen. Harbisson received a specialised electronic eye, his “eyeborg” to be able to render perceived colours as sounds on the musical scale. Google is not the only one working on A.I.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.