TORONTO, Aug. 13, 2018 /PRNewswire/ — 7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module. This achievement is a crucial step in the commercial launch of 7D Surgical’s innovative Machine-vision Image Guided Surgery (MvIGS) system for cranial surgery throughout the United States. […]
NEWS
10 MORE Corpectomy Devices to Know!
Today we have included in our Corpectomy Section (CP) 10 more devices to know. We have included expandable devices as well as other differenciated corpectomy cages (Take into account that some of them may be already out of the market). As we said, there are more than 150,000 spinal fractures in North America* with an […]
NuVasive and Siemens Healthineers partner to transform spine surgery
San Diego and Erlangen, Germany, Aug. 9, 2018 / — NuVasive, Inc. (NASDAQ: NUVA) and Siemens Healthineers today announced a strategic partnership focused on technology development, marketing and commercial activities to advance clinical outcomes in minimally invasive spine surgery. NuVasive is an innovation leader in spine health technology, focused on transforming spine surgery with minimally disruptive, predictable and clinically reproducible procedurally-integrated solutions, […]
Augmedics Begins First-in-Human Clinical Trial of xvision-spine (XVS) Augmented-Reality Surgical Navigation System
YOKNEAM, Israel–(BUSINESS WIRE)–Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. Led by Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and […]
Centinel Spine Announces that UnitedHealthcare Will Now Cover prodisc L Anterior Lumbar Total Disc Replacement
New York, NY, – Centinel Spine, LLC is pleased to announce that UnitedHealthcare®, the nation’s second largest commercial insurer, has issued a positive medical policy for Lumbar Total Disc Replacement (TDR). This decision affects over 16 million patients covered through UnitedHealthcare, and means that three out of the four largest US commercial providers now have positive […]
SI-BONE, Inc. Announces 23 Commercial Health Insurance Plans Now “Exclusively” Cover Triangular iFuse Implant System® Based on Published Clinical Evidence
SAN JOSE, Calif., Aug. 7, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (MIS) treatment of the sacroiliac (SI) joint with the iFuse Implant System® (“iFuse”) announced that 23 commercial health plans have published exclusive positive coverage policies for the triangular iFuse Implant System. These exclusive positive coverage policies provide access to […]
Orthofix Reports Second Quarter 2018 Financial Results
LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (previously Orthofix International N.V.) (NASDAQ:OFIX) today reported its financial results for the second quarter ended June 30, 2018. Net sales were $111.5 million, diluted earnings per share from continuing operations was $0.05 and adjusted earnings per share from continuing operations was $0.42. “During the second quarter, we made excellent progress […]
10 Expandable Corpectomy Devices to Know!
Each year, there are more than 150,000 spinal fractures in North America*. There is an estimated 10,000 to 12,000 spinal cord injuries every year and approximately 39% of these injuries are cause by motor vehicle accidents. These non-elective or trauma surgeries sometimes require additional spinal structural support which is when the Expandable Corpectomy Device are […]
Fuse Medical, Inc. Completes Acquisition of Maxim Surgical
RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc. (OTC: FZMD) (“Fuse” or the “Company”), announced the completion of the acquisition of Palm Springs Partners, LLC d/b/a Maxim Surgical (“Maxim”), a manufacturing company in the spinal fusion device market and full-service medical device and distribution company (the “Acquisition”). The effective date of Acquisition was August 1, 2018. Formed in […]
10 Spine Companies to Know with “P”
The Spine market is dominated by the following 10 global companies:Medtronic, DePuy Synthes, NuVasive Inc, Globus Medical, Stryker Corporation, Zimmer Biomet, K2M Group Holdings Inc, Alphatec Spine and Aesculap Implant Systems But in addition to these companies, there are more than 300 manufacturers worldwide. Many weeks ago, we started to display the updated list of all […]
Alphatec Reports Second Quarter 2018 Financial Results
CARLSBAD, Calif., Aug. 02, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq: ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today reported financial results for the second quarter ended June 30, 2018. Second Quarter 2018 Financial Highlights […]
Newly Published Data Demonstrate Bone In-Growth Potential of Stryker’s 3D-Printed Tritanium® Cage
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced the publication of a pre-clinical animal study comparing the performance of spinal implants made from a variety of materials, which illustrated the bone in-growth and biological fixation capabilities of its 3D-printed Tritanium cages. The study was published in the July issue of The Spine Journal. The purpose of […]
RTI Surgical® and Aziyo® Biologics Announce Exclusive Agreement to Distribute ViBone® for Spine and Other Orthopedic Procedures
ALACHUA, Fla. & SILVER SPRING, Md.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, and Aziyo Biologics, Inc., a fully integrated regenerative medicine company, today announced the signing of an agreement under which Aziyo will provide ViBone to RTI Surgical for exclusive distribution in the U.S. ViBone is a bone repair product designed to […]
Globus Medical Reports Second Quarter 2018 Results
AUDUBON, Pa., Aug. 01, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the second quarter ended June 30, 2018. Worldwide sales were $173.4 million, an increase of 13.8% as reported Second quarter net income was $45.0 million, an increase of 56.9% Diluted earnings per share […]
NuVasive Announces Second Quarter 2018 Financial Results
SAN DIEGO, July 31, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced financial results for the quarter ended June 30, 2018. Second Quarter 2018 Highlights Revenue increased 8.5% to $281.6 million, or 7.7% on a constant currency basis; GAAP operating profit margin of 10.1%; […]
SeaSpine Reports Second Quarter 2018 Financial Results
CARLSBAD, Calif., July 30, 2018 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the quarter ended June 30, 2018 and updated its financial outlook for 2018. Summary Second Quarter 2018 Financial Results and Recent Accomplishments Revenue of […]
Cerapedics Announces First Patients Enrolled in IDE Clinical Trial of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery
WESTMINSTER, Colo., July 30, 2018 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced that the first patients have been enrolled in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the next-generation P-15L Peptide Enhanced Bone Graft in transforaminal lumbar interbody fusion (TLIF) surgery. The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE […]
OrthoPediatrics, Osseus, and many others…! SPINE Catalogue From A to Z: 18 Spine Companies to know with “O”
The Spine market is dominated by the following 10 global companies:Medtronic, DePuy Synthes, NuVasive Inc, Globus Medical, Stryker Corporation, Zimmer Biomet, K2M Group Holdings Inc, Alphatec Spine and Aesculap Implant Systems But in addition to these companies, there are more than 300 manufacturers worldwide. Many weeks ago, we started to display the updated list of all […]
Ulrich Medical USA says a Texas -based hospital owes thousands of dollars for medical devices
ST. LOUIS –– Ulrich Medical USA says a Texas -based hospital owes thousands of dollars for medical devices.The Missouri-based spinal implant manufacturer filed a lawsuit on July 17 in the U.S. District Court for the Eastern District of Missouri, alleging St. Camillus Hospital purchased more than $164,000 worth of devices during 2017 and 2018. But the […]
Nuvasive, Neurostructures, and many others…! SPINE Catalogue From A to Z: 13 Spine Companies to know with “N”
The Spine market is dominated by the following 10 global companies:Medtronic, DePuy Synthes, NuVasive Inc, Globus Medical, Stryker Corporation, Zimmer Biomet, K2M Group Holdings Inc, Alphatec Spine and Aesculap Implant Systems But in addition to these companies, there are more than 300 manufacturers worldwide. Many weeks ago, we started to display the updated list of all […]
NuVasive Unveils Spine’s First Integrated Surgical Automation Platform
SAN DIEGO, July 27, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Pulse™ surgical automation platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pulse is the foundation for Surgical Intelligence™, the Company’s […]
Mighty Oak Medical Receives FDA 510K Clearance for S2AI
July 25, 2018–Englewood, CO – Mighty Oak Medical announced today that its patient-specific, 3D printed FIREFLY® Pedicle Screw Navigation Guides have received an additional FDA 510K clearance for the expanded indications to include S2AI trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries such as scoliosis. The precise mechanical guidance of patient-specific guides is ideal for […]
DePuy Synthes Launches CONCORDE LIFT Expandable Interbody Implant as Part of a New Procedural Solution for Minimally Invasive Spine Surgery (MIS) that Enhances Surgical Efficiency
RAYNHAM, Mass., July 26, 2018 /PRNewswire/ — Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes** is launching the CONCORDE LIFT Expandable Interbody Device in the U.S. The CONCORDE LIFT Implant is designed to treat patients suffering from degenerative disc disease as part of the new offering called UNLEASH MIS TLIF (Transforaminal Lumbar […]
CarboFix’s CarboClear®, Carbon Fiber Pedicle Screw System Has Been Cleared to Be Used in the United States by the FDA
HERZELIYA, Israel, July 26, 2018 /PRNewswire/ — CarboFix Orthopedics LTD., is pleased to announce that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the CarboClear® Carbon Fiber Pedicle Screw System, a novel device to surgically treat oncological patients in the United States. The CarboClear Pedicle Screw System is intended to restore […]
Implanet Opens German Subsidiary
BORDEAUX, France & BOSTON–Regulatory News:Implanet (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its establishment in Germany. Following the opening of the Implanet UK sales branch in June 2018, Implanet continues direct operational expansion in the European […]
NeuroStructures Announces Distribution Agreement Awarded to Centinel Spine
NeuroStructures, Inc. announces that they have concluded a manufacturing and distribution agreement with Centinel Spine® for the Trifore™ Anterior Cervical Plating System. NeuroStructures, Inc. remains the manufacturer of record and Centinel Spine® owns the Trifore™ IP and will add it to their product portfolio under the name Fortos C™. The Trifore™ Anterior Cervical Plating System […]
Mahe Medical USA launches Spine Emergency Screw Removal system and makes it available via Amazon
Mahe Medical USA announced the introduction and availability of its universal spine emergency screw removal system. “Anything that can be done in the OR to help the patient through a procedure in a shorter period of time without impacting the outcome should be celebrated and that’s exactly what the Mahe spine emergency screw removal system […]