FDA Times Mammography Device Patent Extension Clock
Published Date: 11/24/2025
Notice
Summary
The FDA has set the official review period for the ENVISION Mammography Platform, which helps extend the patent protecting this medical device. This means the company can get extra time on their patent, giving them more control and potential profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they have until early 2026 to speak up.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
310-Day Regulatory Review Confirmed
FDA determined the ENVISION MAMMOGRAPHY PLATFORM had a 310-day regulatory review period (0 days testing phase, 310 days approval phase). The PMA was submitted August 31, 2023 and approved July 5, 2024, and this determination establishes the maximum potential length of a patent extension; the applicant seeks 1,163 or 1,198 days of extension.
Public Comment and Petition Deadlines
Anyone may submit comments asking FDA to redetermine the published dates by January 23, 2026, and any interested person may petition FDA regarding the applicant's due diligence during the review period by May 26, 2026.
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