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Latest From SpinalMotion Inc.
According to a recent Medtech Insight report, the European market for artificial spinal discs totaled approximately $145 million in 2012. During the forecast period covered by the report, the combined market is projected to increase at a compound annual rate of 9.2%.
FDA issues two FDASIA-mandated reports to Congress – one on underrepresented subpopulations and the second on small businesses. More regulatory news.
Upcoming workshop will help manufacturers understand when they should submit a new 510(k) for changes to an existing product. CDRH plans to extend early feasibility pilot until May 2014. More regulatory news.
In less than a month, the US Food and Drug Administration (FDA) recently approved three spine PMAs, two for cervical disc replacement devices, and there are two more cervical discs in the queue for near-term PMA approval. All of this activity suggests the $122 million US cervical disc market is about to gear up.
- Implantable Devices