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The Future Of Vision And Eye Care

The Medical Futurist

The California-based firm, Second Sight , the German company, Retina Implant AG, and the French venture, Pixium Vision were the forerunners of the field, developing implantable visual prosthetics to restore vision to patients who are blind as a result of the rare condition of retinitis pigmentosa.

Diabetes 105
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510(k) Modernization 2023

FDA Law

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D., stated, “ We appreciate the IOM’s report on the 510(k) program.

Medical 64
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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.