(MDDIONLINE.COM) –Although FDA doesn’t have to follow the recommendation of its advisory committees, a negative panel vote is never a good sign for a company hoping to bring a new device to the market. Intrinsic Therapeutic learned the hard way Tuesday that it’s usually best if clinical trials follow the protocol that was initially communicated to […]
NEWS
UPDATED: Learn about the 77 most relevant MIS Pedicle Screw Systems
UPDATED List of Product Competition:Leading competitors in the U.S. include the most important companies as DePuy Synthes, Globus Medical, or Stryker. But the majority of competitors in the U.S. minimally invasive spine market are small companies with market shares of 2% or less. In 2015, our MIS section counted for less than 50 Companies with […]
The MIS Pedicle Screw Market is Growing. Competition is Fierce. Learn about the 75 most Relevant Systems.
According to iData Research, the U.S. minimally invasive spinal implants market was valued at $1.62 billion in 2016. This is expected to increase over the forecast period at a CAGR of 3.6% to reach $2.08 billion (iData Research). Traditionally, pedicle screw systems have been implanted through open surgery from posterior approach. However, a growing number […]
Medtronic settles states’ probe into Infuse marketing for $12 million
BOSTON (Reuters) – Medtronic Plc has agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said on Wednesday.Massachusetts Attorney General Maura Healey said the settlement will resolve an investigation by her office […]
OrthoPediatrics Corp. Appoints Samuel D. Riccitelli to its Board of Directors
WARSAW, Ind., Dec. 15, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the appointment of Samuel D. Riccitelli to its Board of Directors as an independent member, effective immediately. The appointment of Mr. Riccitelli brings the Company’s Board to 11 members. Mr. […]
NuVasive Appoints Experienced Spine Executive Michael Piccirillo To Lead New Global Surgeon Education Platform
SAN DIEGO, Dec. 14, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today the expansion of its renowned surgeon education program into a Clinical Professional Development (CPD) global platform for surgeons that integrates surgical training with professional development. This new initiative […]
Surgical Device Maker Xenco Medical Unveils TraumaGPS, the First Trauma Surgery Delivery App for Spinal Implant Systems
SAN DIEGO–(BUSINESS WIRE)–Xenco Medical, a medical device company transforming surgical procedures and healthcare logistics through its use of materials science in single-use implant systems, announces the release of TraumaGPSTM, the first on-demand trauma surgery delivery app with real-time GPS driver tracking for its disposable implant systems. The Android application developed by Xenco Medical allows surgeons […]
NuVasive To Acquire SafePassage
SAN DIEGO, Dec. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, and SafePassage™, a privately-held provider of intraoperative neurophysiological monitoring (IONM) services, announced today that they have entered into a definitive agreement under which NuVasive will acquire SafePassage. Terms […]
VEXIM Announces the Results of the Simplified Tender Offer Initiated by Stryker
BALMA, France–(BUSINESS WIRE)–Regulatory News:VEXIM (Paris:ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures listed on Euronext Growth (FR0011072602 – ALVXM), announces that the simplified public tender offer for the shares and BSAAR warrants of VEXIM (the “offer”), initiated by Stryker France MM Holding SAS (“Stryker”), has closed. The public tender […]
EIT Emerging Implant Technologies Announces Agreement with HCA
ROSWELL, GA (PRWEB) DECEMBER 11, 2017–Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now successfully completed the contracting process with HealthTrust related to an HCA contract and is now able to offer all interbody products for Cervical, […]
Omnia Medical: First PEEK-OPTIMA™ HA Enhanced Vertebral Body Replacement System to Enter US Market
THORNTON CLEVELEYS, UK (PRWEB) DECEMBER 07, 2017–‘Omnia Medical VBR’ has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA™ HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of […]
Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody
WAYNE, Pa., Dec. 7, 2017 /PRNewswire/ — Camber Spine announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™-C Open Matrix Cervical Interbody device, an innovative interbody fusion implant, second in the SPIRA™ family to employ a novel arched design as well as Surface by Design™ technology. This […]
IMPLANET Announces the Signature of a MOU on a Worldwide Partnership with Korean Company L&K BIOMED
BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, announces that it has signed a Memorandum of Understanding with a view to setting up a strategic partnership with Korean company L&K BIOMED. L&K BIOMED is a company listed […]
Antibacterial Benefits of PEKK for Orthopedic Applications Detailed in Study of 3D-Printed OsteoFab® Structures
SOUTH WINDSOR, Conn., Dec. 05, 2017 (GLOBE NEWSWIRE) — Oxford Performance Materials, Inc. (OPM), a leader in advanced materials science and high performance additive manufacturing (HPAM™), today announced the results of an independent scientific study that reveals superior antibacterial properties of 3D printed PEKK (poly-ether-ketone-ketone) structures vs. conventional PEEK (poly-ether-ether-ketone) surfaces for orthopedic applications. The […]
ChoiceSpine™ Announces First Clinical Use of HAWKEYE Ti Device
KNOXVILLE, TENN. (PRWEB) DECEMBER 05, 2017–ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announces the first clinical use of HAWKEYE Ti, a 3D-printed, titanium Vertebral Body Replacement (VBR) device. The first surgery was performed by Joe Ordonez, MD, Neurosurgical Associates, Norfolk, VA at Sentara Norfolk General also in Norfolk, VA. The HAWKEYE […]
Mazor Robotics CEO Suspected Of Insider Trading
December 4, 2017 –Mazor Robotics CEO Ori Hadomi has been the subject of questioning during an ongoing investigation by the Israel Securities Authority, which claims it has reason to believe insider trading took place around the time of a May 2016 agreement with medical device maker Medtronic. Founded in 2001, Nasdaq-listed Mazor develops and manufactures robotic […]
Amedica Receives Positive Nasdaq Listing Decision
SALT LAKE CITY, Dec. 01, 2017 (GLOBE NEWSWIRE) — Amedica Corporation (Nasdaq: AMDA) (the “Company”), an innovative biomaterial company that develops and manufactures silicon nitride as a platform for biomedical applications, announced today that on November 27, 2017, the Company received formal notice from The NASDAQ Stock Market LLC (“Nasdaq”) indicating that the Company has […]
Newly Awarded German Growth Champion joimax® Presents New Products at DWG Stuttgart, Germany, and Broadens Its Education and Congress Activities
IRVINE, Calif.–(BUSINESS WIRE)–joimax®, recently awarded as German Growth Champion 2018, continues to share its expertise in endoscopic minimally invasive spine surgery. With the latest workshops in Krasnodar, RUS, Guadalajara, Mexico and at the Wooridul Hospital in Korea, the company strengthens its outstanding education program. During the workshops, surgeons are trained in endoscopic techniques and other […]
Globus Medical Announces Clinical Results Showing Superiority of its SECURE-C® to ACDF at Seven Years
AUDUBON, Pa., Nov. 30, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced the results of its seven-year clinical trial follow-up that demonstrate superiority of the SECURE-C® Cervical Artificial Disc over the current standard for the treatment of cervical disc disease, anterior cervical discectomy and fusion (ACDF), based on overall […]
SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
CARLSBAD, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable […]
K2M Announces Completion of 300 RHINE™ Cervical Disc System Surgical Cases
LEESBURG, Va., Nov. 30, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced the completion of 300 surgical cases using the RHINE™ Cervical Disc System*. The announcement was made during the 12th Annual Meeting of the German […]
SpineGuard Announces First Order of PediGuard® for China Received from Partner XinRong Medical Group
PARIS & SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today that XinRong Medical Group placed its first large order of Classic PediGuard immediately after the successful launch at the Chinese Orthopaedic Association (COA) annual meeting. The launch meeting […]
Spinal Elements Announces Headquarters And CEO Changes
MARIETTA, GA. (PRWEB) NOVEMBER 28, 2017–Spinal Elements, Inc. today announced plans to move its global headquarters to its Carlsbad, California location. Concurrent with this move, Jason Blain, co-founder of Spinal Elements and currently its President and COO, will assume the role of President and CEO. This change is effective immediately. “I am excited by the […]
EIT Emerging Implant Technologies Announces First Cases Completed Successfully by Top Surgeons in the United States
ROSWELL, GA. (PRWEB) NOVEMBER 28, 2017–Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now performed the first surgeries in the United States and is able to offer all interbody products for Cervical, ALIF, TLIF and PLIF procedures. […]
Medicrea Acquires 3 Patents from Dr. Paul McAfee to Enhance Surgical Planning of 3D-Printed Titanium Interbody Devices
NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has acquired three patents from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center. These patents cover the […]
OrthoPediatrics Corp. to Highlight its Products at the 14th Annual International Pediatric Orthopaedic Symposium
WARSAW, Ind., Nov. 27, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today that it is a Platinum sponsor of the 14th Annual International Pediatric Orthopaedic Symposium (IPOS), taking place November 28 to December 2, 2017 in Orlando, Florida. The IPOS meeting, presented […]
Cervical Artificial Disc Segment Expected to Comprise Nearly €57 million of the Overall Europe Motion Preservation Market by 2023. Learn about the 44 main devices
According to Europe Market Report for Spinal Motion Preservation Devices 2017 – MedCore by iData Research, Inc., procedural growth, favorable reimbursement policies, and its use as an alternative to spinal fusion are driving the European cervical artificial disc market. Growth rates will be maintained due to increased adoption rates and patient education. The total artificial […]