AEROPACE Device Gets Official FDA Patent Review Nod
Published Date: 2/26/2026
Notice
Summary
The FDA has set the official review period for the medical device AEROPACE, which helps the company extend its patent protection. This means the company could get more time to keep exclusive rights to their invention, potentially affecting competitors and consumers. If anyone thinks the dates are wrong or the company wasn’t careful during the review, they can speak up by April 27 or August 25, 2026.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 2 costs, 1 mixed.
FDA Sets 2,802-Day Review Period
The FDA determined the regulatory review period for the medical device AEROPACE is 2,802 days in total: 2,561 days in the testing phase and 241 days in the approval phase. That review-period length is the basis the company can use when applying for up to a 5-year patent extension and may give the company more time to keep exclusive rights, which could affect competitors and consumers.
Applicant Seeks 1,288 Days Extension
Lungpacer Medical, Inc. has applied to the USPTO seeking 1,288 days of patent term extension for U.S. Patent No. 10,765,867 for AEROPACE. The FDA notes its determination establishes the maximum potential length, but the USPTO will apply statutory limitations when calculating the actual extension.
Public Comment and Petition Deadlines
Anyone who believes the published dates are incorrect may ask for a redetermination by April 27, 2026. Any interested person may petition the FDA to challenge whether the applicant acted with due diligence by August 25, 2026, following the petition procedures in 21 CFR 60.30.
FDA Rejects Applicant's Earlier Date Claims
The applicant claimed an IDE effective date of March 2, 2017 and a PMA initial submission date of February 11, 2022, but FDA records show the IDE was effective April 5, 2017 and PMA P240012 was submitted on April 8, 2024. FDA used its dates when determining the regulatory review period.
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