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Intraoperative Imaging for the OR of Today

Intraoperative imaging using MRI brings real-time imaging into the neurosurgical suite, complementing other methods of helping neurosurgeons visualize their operating fields. Neurosurgical interest seems high, but with the technology new and extremely expensive, adoption rates are at a crawl. Two big players, Siemens and GE, are in the market. Now, Odin Medical, an Israeli start-up, is offering a lower cost, but less powerful system that it says is more practical and adequate for neurosurgeon's needs. A new deal with Medtronic's Surgical Navigation Technologies division should help drive sales.

Over the past decade or so, image-guided surgery has evolved to permit surgeons to navigate areas that are visually restricted in the cranium, spine, and sinus passages. These tools, based on diagnostic images taken before the operation, give surgeons roadmaps with landmarks upon which to follow trackable surgical instruments during surgery. However, in the case of tissue resections, organs and structures often shift, so that the surgeon can no longer be sure of their instrument's precise location in the body.

In recent years, imaged-guided surgery companies have begun to incorporate real-time imaging modalities, for example, C-arm fluoroscopy or ultrasound, in...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

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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‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.