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FDA discloses information related to adverse events after use of non-Medtronic devices

June 25, 2017

In a letter to health care providers, the FDA provided information regarding adverse events reported during or following procedures that involved non-Medtronic surgical stereotaxic navigation instruments with Medtronic’s NavLock Tracker.

According to the letter, on May 1, Medtronic reported in a notice that they are aware of occurrences of minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic’s NavLock Tracker. Medtronic notified the FDA of plans to update their product labeling to clarify indications of use and warning statements.

Senate health care bill takes slower approach to House bill, expert concerns persist

June 22, 2017
The Senate health care bill, released to the public today, maintains much from the version the House passed May 4, 2017, but presents some key changes such as a slower…
In the Journals

Similar clinical outcomes seen with hybrid-CDA, ACDF for patients with congenital cervical stenosis

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Investigators of this study found in patients with myelopathy due to congenital cervical stenosis, hybrid-cervical disc arthroplasty had similar clinical improvements as…

AMA supports efforts to improve substance abuse disorder coverage

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Experts from four leading nonprofits in the addiction field have determined that existing legislation does not adequately protect insurance coverage of substance abuse…
FDA News

FDA commissioner calls for public input on lifting generic barriers

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In introducing the FDA’s Drug Competition Action Plan, the commissioner announced his intent to assess ways FDA rules may be misused to create obstacles against…
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