NuVasive wins FDA nod for redesigned Magec system
NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system.
The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system.
The Reline small stature platform is a pediatric deformity fixation system which is designed to improve construct strength and reduce the systems implant profile.
“As a low-profile pediatric fixation system, Reline Small Stature is the first-of-its-kind system to offer competiti...
Source: Mass Device - September 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news
ApiFix Signs Distribution Agreement in Canada; Completes First Cases in North America at IWK Health Centre Hospital, Halifax
MISGAV, Israel, Sept. 5, 2017 -- (Healthcare Sales & Marketing Network) -- Medical device company ApiFix Ltd., a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), announced it signed an exclusive distribution agreement in Canada with Jo... Devices, Orthopedic, Neurosurgery, Distribution ApiFix , Joint Solutions Alliance, Idiopathic Scoliosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 5, 2017 Category: Pharmaceuticals Source Type: news
Thoracic kyphosis in those over 50 may not be a predictor of physical decline
(Hebrew SeniorLife Institute for Aging Research) A recently published study in the Journal of the American Geriatrics Society has found that using CT scans to evaluate early signs of hyperkyphosis (extreme forward curvature of the upper spine) in people over age 50 does not help to identify those at risk of subsequent physical function decline. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 22, 2017 Category: International Medicine & Public Health Source Type: news
Shriner's Hospital for Children launches app to spot signs of scoliosis in children
Parents of growing children have a checklist of things to monitor: ears, eyes, body temperature, the works. Yet aside from scheduling a visit with the doctor, there aren ’t a whole lot of ways to check for signs of scoliosis. That’s where SpineScreen enters the picture.
(Source: mobihealthnews)
Source: mobihealthnews - August 15, 2017 Category: Information Technology Source Type: news
7 medtech stories we missed this week: August 11, 2017
[Image from unsplash.com]From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention.
1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant
Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions for the Calix-C cervical inter body cages. The clearance allows for two larger footprints to be added for use with allograft. The Calix-C Cervical Interbody Spacer is designed for spinal fusion procedures at level one in patients who are skeletally m...
Source: Mass Device - August 11, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Clinical Trials Food & Drug Administration (FDA) Oncology Regulatory/Compliance Spinal Surgical Apifix Cardiac Science Hip Innovation Life Spine Inc. MedTech Pentax Medical Varian Medical Systems Xtant M Source Type: news
One vs Two Surgeons in Adult Scoliosis Deformity Surgery One vs Two Surgeons in Adult Scoliosis Deformity Surgery
Might an additional surgeon help improve adult scoliosis deformity surgery efficiency and outcomes?Spine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 9, 2017 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news
The ApiFix Spinal Implant Receives TGA Certification
MISGAV, Israel, Aug. 8, 2017 -- (Healthcare Sales & Marketing Network) -- ApiFix, a portfolio company of The Trendlines Group, received TGA certification through its distributor Orthotech Pty. Ltd. to begin marketing the ApiFix system in Australia for the... Devices, Orthopaedic, Neurosurgery, Regulatory ApiFix , Trendlines Group, Adolescent Idiopathic Scoliosis, spine surgery (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 8, 2017 Category: Pharmaceuticals Source Type: news
A Better Cervical Collar: Old Myths and New Realities
Cervical immobilization has long been considered an essential first step in addressing trauma patients. For forty years, there has been controversy over risk/benefits of a semi-rigid collar. Some studies have even suggested that collars can even be omitted as long as patients are immobilized until arrival at an ED or trauma center.
Because radiologists have the final say in diagnosing normal vs fracture of cervical spine, we were asked to undertake a study to find the best solution for cervical immobilization. To address this controversy, we used state of the art radiology techniques in assessing jugular venous return and ...
Source: JEMS Operations - August 7, 2017 Category: Emergency Medicine Authors: Robert Hurwitz, MD Tags: Operations Equipment & Gear Source Type: news
A bond between sisters made stronger by scoliosis
Growing up, sisters will often share many things — and not always willingly. But it’s not often they will end up sharing the same condition, one that keeps them stuck in a rigid and uncomfortable back brace for most of the day. But then again, April and Mary Miller are not your average sisters.
The Miller sisters were both diagnosed with idiopathic scoliosis at the end of their fifth grade years. April, the oldest sister, was diagnosed in 2011, while younger sister Mary’s diagnosis came in 2013.
One diagnosis, two separate journeys
Scoliosis is relatively common, with idiopathic scoliosis being its most common for...
Source: Thrive, Children's Hospital Boston - June 26, 2017 Category: Pediatrics Authors: Connor Ertz Tags: Diseases & Conditions Our Patients’ Stories brace idiopathic scoliosis Michael Glotzbecker spinal fusion Spinal Program Source Type: news
Yoga Could Help Heal Chronic Back Pain
BOSTON (CBS) – Healing your back with the help of yoga. It is a simple solution for people suffering from chronic back pain.
A new study, conducted right here in Boston, has found yoga may be an easy answer for some.
Judith Zaborowski, who has significant arthritis in her spine, takes yoga. The 74-year-old says the practice helps ease her back pain.
(WBZ-TV)
“I’m much more comfortable with movement,” Judith explains.
Now a new study from Boston Medical Center backs that up. Researchers looked at more than 300 low-income patients with chronic lower back pain. Some took yoga classes designed for back pain on...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - June 19, 2017 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health Local News Syndicated Local Watch Listen Dr. Mallika Marshall Yoga Source Type: news
Experiencing how spinal fusion treats scoliosis before surgery day
The Spinal Program at Boston Children’s Orthopedic Center has partnered with the Simulator Program to offer a unique simulation experience to patients who will undergo surgical treatment for scoliosis, a procedure called spinal fusion, this summer.
“In my experience, patients do better when they are well prepared for surgery,” says Dr. Michael Glotzbecker, a pediatric spine specialist and surgeon at Boston Children’s Hospital, who performs dozens of spinal fusion surgeries each year to treat children with scoliosis.
That’s why Glotzbecker teamed up with Brianna O’Connell, a child l...
Source: Thrive, Children's Hospital Boston - June 5, 2017 Category: Pediatrics Authors: Kat J. McAlpine Tags: Research and Innovation Michael Glotzbecker Orthopedic Center scoliosis Simulation Program spinal fusion surgery Source Type: news
Scoliosis severity index could help identify progressive adolescent idiopathic scoliosis (AIS)
A study published in the June 1 issue of the journal Spine attempts to identify an early detectable severity index for progressive adolescent idiopathic scoliosis (AIS). (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - June 4, 2017 Category: Orthopaedics Tags: Featured Editors Choice News Source Type: news
Evidence Lacking to Support Screening Kids, Teens for Scoliosis
A recently issued U.S. Preventive Services Task Force draft recommendation says evidence is insufficient to recommend screening for adolescent idiopathic scoliosis in patients ages 10-18. (Source: AAFP News)
Source: AAFP News - June 1, 2017 Category: Primary Care Source Type: news
USPSTF: Not Enough Evidence to Recommend Routine Scoliosis Screening (FREE)
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The U.S. Preventive Services Task Force now says there ' s not enough evidence to weigh the benefits and harms of screening … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - May 31, 2017 Category: Primary Care Source Type: news
100 Most Influential Publications in Scoliosis Surgery 100 Most Influential Publications in Scoliosis Surgery
This article highlights the 100 most important publications in the field of scoliosis surgery research.Spine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 29, 2017 Category: Consumer Health News Tags: Orthopaedics Journal Article Source Type: news
