Strasbourg, France,May 9, 2024. SC MEDICA, leader in facet fixation solutions, today announced that it has obtainedregulatory clearance from the United States Food and Drug Administration (FDA) for its medical device FFX®, a facet fixation system for use in lumbar spinal fusion surgery. This achievement was supported by compelling clinical evidence comparing FFX® and pedicle … [Read more...] about SC MEDICA Announces Landmark FDA Clearance For Its FFX® Facet Cage For Lumbar Spinal Fusion.
NEWS
Lenoss Medical Oversubscribes $4 Million Series A Financing
Funding will accelerate commercialization, expand clinical evidence, and fuel innovative product development PROVIDENCE, RI (May 9, 2024) — Lenoss Medical, a pioneering medical device company developing the innovative OsteoPearl biological allograft implant to address the critical need for osteoporotic vertebral compression fractures, today announced the successful … [Read more...] about Lenoss Medical Oversubscribes $4 Million Series A Financing
Biogennix Receives FDA Clearance for Expanded Use of Two Moldable products
IRVINE, Calif. — May 8, 2024 — Irvine-based Biogennix, LLC an osteobiologics company specializing in bone graft products for fusion procedures, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication for its Agilon Moldable and Morpheus Moldable bone grafting products. The new clearance allows the … [Read more...] about Biogennix Receives FDA Clearance for Expanded Use of Two Moldable products
ATEC Reports First Quarter 2024 Financial Results and Raises Full-Year Guidance
CARLSBAD, Calif.--(BUSINESS WIRE)-- Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, today announced financial results for the quarter ended March 31, 2024, and recent corporate highlights. First Quarter 2024 Financial Results First Quarter Highlights “The time to be spine’s … [Read more...] about ATEC Reports First Quarter 2024 Financial Results and Raises Full-Year Guidance
Globus Medical Reports First Quarter 2024 Results
AUDUBON, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced its financial results for the quarter ended March 31, 2024. “Since the NuVasive merger closed in September of last year, we worked aggressively to execute our integration strategy and are making … [Read more...] about Globus Medical Reports First Quarter 2024 Results
MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
WASHINGTON, May 7, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and healthcare advisory firm is proud to announce its role in supporting Orthobond with achieving a granted US Food and Drug Administration (FDA) De Novo for the Mariner Pedicle Screw System with Ostaguard™ coating. … [Read more...] about MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
SI-BONE Expands Portfolio with the Launch of New Offering for the iFuse Bedrock Granite Implant System and Completes Inaugural Surgical Procedures
SANTA CLARA, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy, announced the first cases completed with the smaller, 9.5 mm diameter, iFuse Bedrock Granite® Implant (Granite 9.5). When placed across the SI joint, the Granite implant … [Read more...] about SI-BONE Expands Portfolio with the Launch of New Offering for the iFuse Bedrock Granite Implant System and Completes Inaugural Surgical Procedures
Facet Replacement FDA Study Garners Best Paper Award At Lumbar Spine Research Society Meeting
NORWALK, Conn., May 2, 2024 /PRNewswire-PRWeb/ --Premia Spine, a leader in innovative spinal treatment solutions, today announced that the pioneering study titled "Lumbar Facet Arthroplasty for Degenerative Spondylolisthesis with Stenosis: Interim Analysis of Three-Year Outcomes from a Prospective Randomized Clinical Trial" has been awarded the prestigious Best Paper at … [Read more...] about Facet Replacement FDA Study Garners Best Paper Award At Lumbar Spine Research Society Meeting
ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System
Misgav, Israel, 06 May 2024 – ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s … [Read more...] about ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System
OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis
WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address … [Read more...] about OrthoPediatrics Corp. Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis
Stryker reports first quarter 2024 operating results
Portage, Michigan, April 30, 2024 (GLOBE NEWSWIRE) -- Stryker (NYSE:SYK) reported operating results for the first quarter of 2024: First Quarter Results "Our momentum from 2023 continued into the first quarter as we delivered 10% organic sales growth," said Kevin A. Lobo, Chair and CEO. "Our teams are executing well and I am confident in our ability to grow sales … [Read more...] about Stryker reports first quarter 2024 operating results
Curiteva Announces David Schmidt as Chief Commercial Officer
Huntsville, AL (April 26, 2024) – Curiteva, a privately held manufacturing and technology company announces the appointment of David Schmidt as Chief Commercial Officer, marking a significant milestone in the company’s mission to advance innovative technology in patient care. With a distinguished career spanning over two decades, Mr. Schmidt brings unparalleled … [Read more...] about Curiteva Announces David Schmidt as Chief Commercial Officer
SpinEM Robotics and Spineart Forge Strategic Partnership with €10 Million Investment
GENEVA and SAINT-MARTIN D'HÈRES, France, April 30, 2024 /PRNewswire/ -- SpinEM Robotics, a leading deep tech startup specializing in cutting-edge navigation solutions for robotic spinal surgery, is thrilled to announce a significant milestone in its innovation journey. The company has successfully closed a Series A2 funding round, securing a €10 million ($11 … [Read more...] about SpinEM Robotics and Spineart Forge Strategic Partnership with €10 Million Investment
nView medical Announces First Adult Spine Surgery Using Groundbreaking nView s1 Imaging and Navigation Technology
SALE LAKE CITY, April 29, 2024 /PRNewswire-PRWeb/ -- nView medical, a leader in surgical imaging technologies, proudly announces the successful first use of its nView s1 imaging and navigation system in adult spine surgery. The procedure was performed at the prestigious Semmes-Murphey Clinic in Memphis, TN, by pioneer Kevin T. Foley, M.D. This … [Read more...] about nView medical Announces First Adult Spine Surgery Using Groundbreaking nView s1 Imaging and Navigation Technology
Aclarion’s Nociscan Solution to Play Key Role in Groundbreaking LIFEHAB Trial Evaluating the Diagnosis and Treatment of Chronic Low Back Pain
BROOMFIELD, CO, April 25, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW),a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that the Nociscan solution will be utilized in … [Read more...] about Aclarion’s Nociscan Solution to Play Key Role in Groundbreaking LIFEHAB Trial Evaluating the Diagnosis and Treatment of Chronic Low Back Pain
joimax® Obtains Registration for All Products in the Indian Market
KARLSRUHE, Germany--(BUSINESS WIRE)--German-based joimax®, the market leader in technologies and training methods for full-endoscopic and minimally invasive spinal surgery, is excited to announce the full registration of all its products for India, one of the fastest growing endoscopic spine surgery markets worldwide. The Indian registration includes all joimax® Class II and … [Read more...] about joimax® Obtains Registration for All Products in the Indian Market
4WEB Medical Announces Regulatory Clearance of its Anterior Spine Truss System with Anchor Fixation
DALLAS, April 25, 2024 /PRNewswire/ -- 4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, announced that it received regulatory clearance to market the newest addition to the company's anterior lumbar implant portfolio, the Anterior Spine Truss System with Anchor Fixation … [Read more...] about 4WEB Medical Announces Regulatory Clearance of its Anterior Spine Truss System with Anchor Fixation
Captiva Spine shares the publication of a prospective randomized comparative Clinical Study of Accuracy and Safety data in line with the WatchTower Spine Navigation System
Jupiter, FL – April 2024 – Captiva Spine®, a medical technology organization connecting healthcare professionals, distribution specialists, and healthcare facilities with cutting-edge spinal care technology, shares a recently published study in the Journal of Neurosurgery: Spine (JNS), affirming the effectiveness of the WatchTower Spine Navigation System and its novel 2D … [Read more...] about Captiva Spine shares the publication of a prospective randomized comparative Clinical Study of Accuracy and Safety data in line with the WatchTower Spine Navigation System
Centinel Spine® Hits Another Revenue Record in First Quarter 2024 as prodisc® Total Disc Replacement Worldwide Growth Momentum Continues
WEST CHESTER, Pa., April 23, 2024 /PRNewswire/ -- Centinel Spine®, LLC ("the Company"), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced achievement of record revenue in … [Read more...] about Centinel Spine® Hits Another Revenue Record in First Quarter 2024 as prodisc® Total Disc Replacement Worldwide Growth Momentum Continues