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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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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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Dxcover Launches US Operations With New Headquarters In Tennessee

 
• By Natasha Barrow

Dxcover sets up new Clinical Laboratory Improvement Amendments (CLIA) lab in Franklin, Tennessee.

EnsoData Boosts AI Sleep Tech With $20M Series B Funding, Targets Underdiagnosis Crisis

 
• By Shubham Singh

EnsoData positions itself as device-agnostic and interoperable, with FDA-cleared software that can integrate with all major devices. CEO Mortara said this flexibility helps maximize patient reach by enabling both direct provider engagement and integration with device manufacturers.

FDA Blocks Some Olympus Endoscopes From Entering US

 
• By Brian Bossetta

After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.