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Spinal News
Wenesday, 12 December 2018   
Spinal News

Top stories

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Dedicated surgical teams improve quality, safety and value in surgery for adolescent idiopathic scoliosis

Dedicated surgical teams have been found to reduce surgical times and room times in patients with adolescent idiopathic scoliosis (AIS). John Smith and colleagues announced this result in a presentation at the 53rd annual meeting of the Scoliosis Research Society (SRS; 11–13 October, Bologna, Italy).

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US FDA plan shakeup of its 510(k) clearance programme

The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about 20% of current 510(k) devices are approved on trials that compare novel devices to predicate devices that are more than 10 years old. With its revised programme, the agency wants to ensure medical devices coming to market account for advances in technology or demonstrate that they meet more modern safety and performance. 

Profile

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Donna Ohnmeiss

Donna Ohnmeiss speaks to Spinal News International about why she chose to put her degree in mathematics to use in clinical research, and how her work on healthcare outcomes ultimately led to her position on the Board of Directors of the North American Spine Society. She warns readers of the rise in predatory publishing, explaining how it is threatening the peer-review process, and touches on the most exciting developments in today’s spinal space.

Feature

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Combating the rise in predatory publishing

Christopher M Bono warns of the rise in predatory publishing, drawing on his own experiences of falling for a well-worded scam email. As editor-in-chief of the North American Spine Society’s flagship publication The Spine Journal, Bono speaks of his regret at how this action helped prop up the network of “fake” journals, and advocates for the #peersforpeers campaign, a movement emphasising the critical role that peer review plays in medical publishing.

Spinal News

Video coverage of NSpine

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Sacral and pelvic osteotomies

Jean Charles Le Huec (Bordeaux University Hospital, Bordeaux, France) gave a talk at the last NSpine meeting on when and how to do sacral and pelvic osteotomies. 

Industry news

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Successful first-in-human for zLOCK system

The successful start of a first-in-human clinical study for the zLOCK spinal facet joint fixation system (ZygoFix) has been announced. The clinical study comprises several procedures to date and a six-month follow-up of the first case. The first case, a fusion procedure using the zLOCK system, was performed on a 67-year-old female suffering from severe back and leg pain.

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Joimax introduces Endoscopic Generation 4

At the 2018 annual meeting of the German Spine Society (DWG; 6–8 December, Wiesbaden, Germany), joimax introduced its Endoscopic Generation 4 Devices and showcased its new 3D-printed titanium implants. This marked the global launch of both the Camsource LED and Vitegra devices, including in Europe, Asia, and the USA.

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FDA advisory committee to review Evenity

The FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) are to review data supporting the Biologics License Application (BLA) for Evenity (romosozumab; Amgen and UCB) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on 15 January, 2019.

Events

 

13–15 December

12th New York City MIS, Robotics & 3D Navigation Symposium: Case Based and Hands-On

New York, USA

 

18–19 January

Global Neurosurgery 2019: A Practical Symposium

New York, USA

 

26–28 March

2nd Combined Meeting with NASS, SOSSOP, APSS, OASAC-SAARC and POS

Lahore, Pakistan

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