MINERAL SPRINGS, N.C. (PRWEB) JULY 14, 2022 Cutting Edge Spine (CES), a leader in the organic development and commercialization of bioactive implant technologies for the spine, today announced the FDA 510(k) clearance of its proprietary SI Joint Fusion System, T-FIX 3DSI Joint Fusion System. The 3D-printed T-FIX 3DSI Joint Fusion System is part of the novel EVOL-SI Fusion […]
NEWS
VisAR Augmented Reality Surgical Guidance System Using Low-Cost Off-the-Shelf HoloLens 2 Hardware Achieves Remarkable Results in Spine Surgery
SALT LAKE CITY, July 15, 2022 /PRNewswire/ — Novarad™ announced the publication of the article Augmented Reality Spine Surgery Navigation: Increasing Pedicle Screw Insertion Accuracy for Both Open and Minimally Invasive Spine Surgeries authored by surgeons participating from University of Utah, Georgetown University and University of Washington in the June 2022 issue of SPINE (volume 47, number 12). The article presents accuracy data for open and minimally invasive pedicle […]
Waypoint Orthopedics Submits 510(k) Application for Waypoint GPS™
MALVERN, Pa., July 15, 2022 (GLOBE NEWSWIRE) — Waypoint Orthopedics, Inc., a spinal instrumentation company, announced the company’s recent submission of an FDA 510(k) application for the Waypoint GPS™ – a smart bone awl for use during pedicle screw pilot hole drilling. The system is designed to provide the surgeon visual feedback that indicates a […]
Surgalign Announces Partnership with PRIA Healthcare to Improve Patient Healthcare Coverage
DEERFIELD, Ill., July 14, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, announced PRIA Healthcare will serve as a strategic partner in support of the recently launched Surgalign™ Patient Access Program. The objective of the Surgalign […]
FDA Accepts&Closes Empirical Spine`s LimiFlex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion
SAN CARLOS, Calif., July 13, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug […]
Centinel Spine® Receives FDA Approval for 3 Additional prodisc® Cervical Total Disc Replacement Devices
WEST CHESTER, Pa., July 13, 2022 /PRNewswire/ — Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced U.S. Food and Drug Administration (FDA) Pre-Market Application (PMA) Approval for 1-level indications for three additional cervical total disc replacement (TDR) devices: prodisc C Vivo, prodisc C Nova, and prodisc C SK. […]
Spineway: Improvement of the activity : significant increase of 1st 2022 semester turnover
Ecully, July 13th 2022 – 6.00pm–Revenue for the first half 2022 : + 65% Committed to a growth trajectory, Spineway saw its sales accelerate over the 2nd quarter 2022 to total turnover of 1,8 M€, an increase of 74% compared to last year, despite a still fragile and uneven context of recovery in the areas where it operates. This performance brings revenue for the first half […]
SpineGuard posts 20% revenue growth in Q2-2022
PARIS and BOULDER (CO), July 12, 2022 – 6:00 pm CEST – SpineGuard (FR0011464452 – ALSGD), an innovative company that deploys its DSG® (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, announced today its first half 2022 revenue. Pierre Jérôme, Co-founder, Chairman and CEO of SpineGuard, declared: “Driven by […]
SMAIO: First-half 2022 Sales up +28% to €1.3 Million
SMAIO (Software, Machines and Adaptative Implants in Orthopaedics – Euronext Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA) (Paris:ALSMA), a French player specialized in complex spine surgery with a global offer comprising software, adaptative implants and related services, today published its sales for the first half of 2022. Philippe ROUSSOULY, Chairman and CEO of SMAIO, commented: “We recorded a solid first half […]
Accelus Announces Series D Equity Financing Led by Concord Health Partners (CHP)
PALM BEACH GARDENS, Fla., July 12, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced the closing of a $12 million lead investment in the company’s Series D equity financing by Concord Innovation Fund […]
Mediliant Group Welcomes Another Medical Device Expert to Their Leadership Team
LE LOCLE, SWITZERLAND (PRWEB) JULY 12, 2022–Leaders in medical device contract manufacturing, the Mediliant Group, has today announced Rob Debney as the company’s new Vice President of Sales and Marketing. With a mission to further enhance the company’s services and answering to their customer’s needs, The Mediliant Group has added Mr. Debney to their leadership team […]
ZimVie Announces Positive Policy Decision from Anthem for Anterior Vertebral Body Tethering, Expanding Coverage to 30+ Million Lives
WESTMINSTER, Colo., July 12, 2022 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental and spine markets, today announced that Anthem Blue Cross Blue Shield (BCBS), a subsidiary/operating company of Elevance Health, has issued a positive medical policy decision applicable to anterior vertebral body tethering (AVBT), effective July 6, […]
Nexxt Spine Announces Early Significant Clinical Evidence Results and Completes Enrollment for NEXXT MATRIXX 3-D Printed Technologies
NOBLESVILLE, Ind., July 12, 2022 (GLOBE NEWSWIRE) — Nexxt Spine, LLC a leader in design and development of 3D printed, porous, titanium implants for the treatment of spinal disorders, announced the completion of enrollment and 6 month clinical data collection comparing the NEXXT MATRIXX® 3-D Printed titanium interbody family to Poly-Ether-Ether-Ketone (PEEK) devices. Nexxt Spine President, Andy […]
Aurora Spine Announces New FDA indication clearance of Lumbar Spinal Stenosis for its ZIP™ series of MIS implants
CARLSBAD, Calif., July 12, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a manufacturer of innovative spinal implants, today announced the FDA clearance of a new Lumbar Spinal Stenosis Indication for Use for its ZIP™ family of MIS implants. Spinal Stenosis occurs when the spinal canal narrows […]
IMPLANET Reports Its Revenue for Q2 2022, Up 33%
Bordeaux, Boston, July 11, 2022 – 06:00 pm CEST: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral implants, today announced its revenue for the second quarter of 2022. Ludovic Lastennet, IMPLANET’s Chief Executive Officer, stated: “Despite the difficulties linked to the lack of personnel in […]
Safe Group announces half-year sales of €2.75 million, 27% growth
Eragny-sur-Oise, Fleurieux sur l’Arbresle, France, July 7th, 2022 5:45pm CET – Safe (FR0013467123 – ALSAF), a company specializing in the design, manufacturing and marketing of single-use technologies for spinal surgeries, delivering the safest treatment for spinal fractures urgently treated, announces its half-yearly revenues for the period ending June 30, 2022. “Safe Group closes the first half of 2022 […]
Surgalign™ Announces Clinical Site Expansion in the Commercialization of its HOLO Portal™ Surgical Guidance System in Ohio
DEERFIELD, Ill., July 06, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc., (NASDAQ: SRGA) a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, today announced continued momentum in the commercialization of its HOLO Portal surgical guidance system. The Company is pleased to report that Selvon St. […]
Additive Implants Announces Initial Surgeries for SureMAX-SA™, StandAlone Cervical Spacer
PHOENIX, July 05, 2022 (GLOBE NEWSWIRE) — Additive Implants, Inc., a medical technology company focused on addressing unmet spine surgeon needs, is pleased to announce the first implantations of the SureMAX-SA™ Cervical StandAlone, the third system in the family of SureMAX Cervical Spacers. The SureMAX-SA™ is a 3D-printed titanium device offering unmatched options in cervical spacer design. […]
Oxford Performance Materials Announces Agreement with Fuse Medical to Develop New Spinal and Sports Medicine Implants
SOUTH WINDSOR, CONN. (PRWEB) JULY 05, 2022 Oxford Performance Materials, Inc. (OPM), an industry leader in advanced polymer science and 3D printed orthopedic devices, announced today an agreement with Fuse Medical, Inc. (Fuse) a manufacturer and distributor of innovative medical devices, to develop new, world-class spinal, extremity and sports medicine implant product lines utilizing OPM’s patented OsteoFab® PEKK technology. […]
3Spine, Inc. Completes First US Surgeries
CHATTANOOGA, Tenn., June 29, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today announced completion of the first series of US surgeries in the BalancedBack Total Joint Replacement Investigational Device Exemption (IDE) pivotal clinical trial. All patients enrolled in the IDE will receive the MOTUS device and will […]
NuVasive Opens Singapore Experience Center for Asia-Pacific region
SAN DIEGO, June 29, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, announced the grand opening of its Singapore Experience Center for the Asia-Pacific region, supporting the Company’s growth strategy to globalize its business. “The NuVasive Singapore Experience Center demonstrates our continued global commitment […]
Implanet Announces a Commercial, Technological and Financial Partnership With Sanyou Medical, a Chinese Manufacturer of Medical Devices for Spine Surgery
Bordeaux, Boston, June 29, 2022 – 05:45 pm CEST: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral implants, announced today the signing of an agreement defining the principles of a strategic, technological and financial partnership project with Sanyou Medical, a Chinese manufacturer of medical devices […]
Medtronic receives spine industry’s first and only FDA clearance for breakthrough device indicated for ligament augmentation
Medtronic plc, a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Breakthrough Device designation for its novel LigaPASS™ 2.0 Ligament Augmentation System. LigaPASS™ is the first and only FDA cleared device with indication for ligament augmentation in spine surgery. Ligament augmentation has been studied for its impact […]
Cresco Spine closes seed investments to develop innovative dynamic surgical therapy for scoliosis
Cresco Spine, a new player in the spinal arena and a spin-off of the University Medical Center Utrecht (the Netherlands), today announced that it raised seed investments from InSpine and Utrecht Health Seed Fund (UHSF) to continue its development of their unique surgical spinal correction platform “Dynamic Implant SolutionsTM” (DISTM), initially focused on early onset […]
Spineway: New development dynamics and confirmed business strategy
Ecully, June 24th, 2022 – New momentum for a strong comeback on the French market A nice presence of Spineway at the SFCR Congress, the representative organization of the spinal surgical specialty in France, early June 2022 in Nice. This congress was the opportunity to present several new products for the first time and, in particular the ranges resulting from […]
3Spine, Inc. Announces IDE Approval
CHATTANOOGA, Tenn., June 22, 2022 /PRNewswire/ — 3Spine, Inc., a medical device company developing total joint replacement for the lumbar spine, today announced FDA Investigational Device Exemption (IDE) approval for their US pivotal clinical trial. The company previously completed contracting and site initiation at 16 US centers for a prospective real-world evidence (RWE) fusion study, which has […]
SeaSpine® Announces Full Commercial Launch of WaveForm® C 3D-printed Interbody System
CARLSBAD, Calif., June 21, 2022 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the full commercial launch of the WaveForm C Interbody System. The WaveForm C Interbody System, SeaSpine’s first cervical 3D-printed interbody, has the highest strength-to-porosity ratio compared […]