Julie Vetalice, Author at ORTHOWORLD

OrthAlign Receives FDA Clearance for Direct Anterior Approach HipAlign

OrthAlign received FDA 510(k) clearance to market the Direct Anterior Approach HipAlign® system, a handheld computer that provides cup placement accuracy data and measurement changes in leg length and joint offset.

Jan 25, 2017

Study Results: iFuse vs. SI Joint Fixation with Screws

ORTHOFLASH Spine

Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE’s iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.

Jan 23, 2017

Camber Spine FDA 510(k) Clearance for Siconus SI Joint Fixation

ORTHOFLASH Spine

Camber Spine Technologies received FDA 510(k) clearance for the Siconus™ SI Joint Fixation System for the treatment of sacroiliac disease.

Jan 23, 2017

7D Surgical Receives US and Canada Regulatory Clearance for Spinal Image Guidance System

ORTHOFLASH Robotics/Tech

7D Surgical received regulatory clearance in the U.S. and Canada to market MvIGS™, the Machine-vision Image Guided Surgery system for spinal procedures.

Jan 23, 2017

Amplitude Surgical Receives 510(k) for Anatomic Knee

Joint Replacement ORTHOFLASH

Amplitude Surgical received FDA 510(k) clearance to market the Anatomic® implant for the treatment of degenerative knee disease.

Jan 20, 2017

2016 Funding Recap

Investments The Numbers

The majority of 2016 investments came in from venture firms, though Johnson & Johnson, Medtronic, Musculoskeletal Transplant Foundation and Orthofix also backed certain financing deals. Similar to recent years, the spine market was the largest target for funding.

Jan 20, 2017

Year in Review: First 510(k)s in 2016

Company Updates Competitive Landscape

The following 18 companies received their first FDA 510(k) in 2016. Whats interesting is that some companies like CG Bio, Meril Life Sciences and Overmed were founded in 2006a decade ago. Another, such as Onkos Surgical, was founded as recently as 2015.

Jan 19, 2017

Orthofix Announces Resolution of SEC Investigations

Company Updates Competitive Landscape

Orthofix reached final resolutions of two previously-disclosed SEC investigations and agreed to pay ~US $14.0MM to settle charges regarding historic accounting matters and anti-bribery matters in Brazil.

Jan 19, 2017

Bovie Medical Enters Sales Partnership with ConMed

Company Updates Competitive Landscape

Bovie Medical entered into a global sales channel partnership agreement with CONMED for its PlazXact™ Ablator, which will be marketed as the UltrAblator Bipolar® series effective in late 1Q17.

Jan 19, 2017

Precision Spine Receives FDA 510(k) Clearance for ShurFit ACIF 2C System

ORTHOFLASH Spine

Precision Spine received FDA 510(k) clearance of its ShurFit® ACIF 2C Anterior Cervical Interbody System, featuring a titanium + hydroxyapatite coating to support bone growth.

Jan 18, 2017

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