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The New Movement in Spine: Sparing the Rod and Growing the Market

The vitality and dynamism in spine surpasses any other medical device segment. Although it's still early in the field, there's a clear first mover advantage, given the long development cycle of spine devices. The time to place bets is now.

Arthroplasty of the spine, the replacement of a disc or nucleus in an effort to repair damaged vertebrae, will be, according to several companies that each spent more than $300 million to acquire their way into it, including Johnson & Johnson , Medtronic Inc. , and Synthes-Stratec (see Exhibit 1)[See Deal], [See Deal], [See Deal], a $3 billion industry five years from now. It's all about preserving motion in the repair of damaged discs for patients who, otherwise, have no middle ground between exercise or a permanent anatomy-altering spinal fusion surgery.

But arthroplasty is only part of a broader technology explosion that has come to the spine market, once one of...

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• By Natasha Barrow

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MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

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