92 results found.
        
Strategic orthopaedic-related 510(k)s issued in May 2017
Strategic orthopaedic-related 510(k)s issued in May 2017 include: Locking Plate System (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (
SI-BONE Receives FDA Clearance for iFuse-3D
SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant.
iFuse SI Fusion Implant Covered by TRICARE
TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minim...
SI-BONE 6-year Clinical Results of iFuse Implant System
Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequen...
NICE Recommendation for MIS SI Joint Fusion Surgery
The U.K.'s National Institute for Health and Care Excellence published guidance recommending availability of minimally invasive sacroi...
SI-BONE Milestone: 25,000 iFuse Procedures Performed Worldwide
SI-BONE's iFuse Implant System® for SI joint fusion has been used in >25,000 procedures worldwide.
Study Results: iFuse vs. SI Joint Fixation with Screws
Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion...
2016 Funding Recap
ORTHOWORLD reported that 15 companies secured funding of more than $10 million in 2016. Below, we recap these announcements. The majority of 2016 investments came in from venture firms, though Johnson & Johnson, Medtronic, Musculoskeletal Transplant Foundation and Orthofix also backed c...
SI-BONE Announces iFuse Implant System Warranty
SI-BONE enacted a warranty program for the iFuse Implant System®, indicated for fusion for certain disorders of the sacr...
CMS Publishes 2017 Final Rule Increasing Outpatient Facility Reimbursement for MIS SI Joint Fusion
CMS issued its 2017 Final Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center payment rule for MI...
2-Year Results from SI-BONE iFuse INSITE Trial
Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BON...
NASS Preview: NASS Stresses a Proactive Approach to Drive Reimbursement in Spine
By Carolyn LaWell Surgeons and device companies face a similar challenge with reimbursem
1H16 Funding Recap: Spine Remains Dominant Market for Investments
ORTHOWORLD reported 18 funding announcements in 1H16, compared to 23 in 1H15. Similar to recent years, the spine market was the largest target for funding. Half of the announcements in 1H16 were made by companies seeking to commercialize products for spinal indications, while three more have prod...
SI-BONE Closes $20MM Round of Growth Financing
SI-BONE closed a US $20MM round of growth capital financing. Proceeds will support U.S. sales expansion and 
SI-BONE Receives 510(k) Clearance on Updated Indication for iFuse Implant
SI-BONE received FDA 510(k) clearance of a modified indication for the iFuse Implant System®, n...
SI-BONE's iFuse Surpasses 20,000 Surgeries
Since launch in 2009, SI-BONE's iFuse Implant System® has been used in >20,000 procedures worldwide. The product was recently...
CoreLink Launches Entasis SI Joint Fusion System
CoreLink commenced U.S. launch of Entasis™, reportedly the only sacroiliac joint fusion system that self-harvests...
Study Results Show Benefits of SI Joint Fusion after Two Years
Results from a 2-year study of SI-BONE’s iFuse implant for sacroiliac (SI) joint fusion show that imp...
National Government Services Issues Coverage for MIS SI Joint Fusion
National Government Services issued a positive local coverage determination for MIS SI joint fusion, including ...
CGS Administrators Establishes Positive Coverage for MIS SI Joint Fusion Effective 2/1/16
CGS Administrators, the Medicare administrative contractor covering Kentucky and Ohio, issued a positive local coverage de...
Investors Shy From Start-Up Risk, Continue to Back Growth-Stage Companies
By Carolyn LaWell Investors continue to back growth-stage device companies and those at the intersection of medical and information technology, as opposed to start-ups—a trend that is expected to endure in 2016. The investment community’s oppositio...
Oxford Finance, Silicon Valley Bank Close $39.2MM Credit Facility with SI-BONE
Oxford Finance and Silicon Valley Bank announced the closing of a US $39.2MM credit facility...
Strategic Orthopaedic-related 510(k)s Issued in October 2015
Strategic orthopaedic-related 510(k)s issued in October 2015 include: Phin-Fx Cannulated Lag Screw (Ascent Medical), Interference Screw (Dun...
SI-BONE iFuse Implant Receives FDA Clearance Reflecting 1-Year Clinical Data
FDA cleared SI-BONE's iFuse Implant System® to include in its indication statement that
CMS Issues 2016 Hospital Outpatient Prospective Payment System Recommendation for MIS SI Joint Fusion
Centers for Medicare & Medicaid Services issued its 2016 Hospital Outpatient Prospective Payment System recommendation for MIS SI joint ...
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