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To currently available IOLs are approved by the FDA for use in labeling and advertising - gpo

To currently available IOLs are approved by the FDA for use in labeling and advertising - gpo 2025

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The document outlines regulations regarding the eligibility, payment adjustments, and operational requirements for Intraocular Lenses (IOLs) approved by the FDA for use in Medicare. It details criteria for IOLs to qualify as new technology, including evidence of improved clinical outcomes compared to existing options. The Centers for Medicare & Medicaid Services (CMS) is responsible for determining payment adjustments based on submitted information and public comments. Additionally, it covers the structure and operation of Health Maintenance Organizations (HMOs) and Competitive Medical Plans (CMPs), including their obligations under Medicare contracts, enrollment processes, and compliance with federal regulations.

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The FDA recently approved an IDE for the Juvene IOL from LensGen, which means that a clinical trial in the U.S. is imminent and hopefully full FDA approval will be granted in the coming years once trial data are analyzed.

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The IC-8 (AcuFocus Inc., California, USA) is a single piece hydrophobic acrylic posterior chamber IOL which combines small aperture optics with a monofocal IOL to achieve extended depth of focus.