FDA Sets Review Period to Extend Diamondback Atherectomy Device Patent
Published Date: 9/29/2025
Notice
Summary
The FDA has officially set the review period for the DIAMONDBACK 360 heart device, helping its makers extend their patent protection. This means the company can get extra time to keep their invention exclusive, which could impact when generic versions appear. If you’re in the medical device world, this timing update is a big deal for innovation and competition.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Sets Review Period for DIAMONDBACK 360
The FDA has officially determined the regulatory review period for the DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE and published a notice of that determination. That determination was made because the company submitted an application to the Director of the U.S. Patent and Trademark Office seeking extension of a patent that claims this medical device, which can give the maker extra time of exclusivity and may affect when competing versions appear.
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