Julie A. Vetalice, Author at ORTHOWORLD

Tenon Medical Gains FDA Clearance for Catamaran Sacroiliac Joint Fixation

Tenon Medical received FDA 510(k) clearance to market the Catamaran Sacroiliac Joint Fixation system, indicated for sacroiliac joint fusion to treat joint disruptions and degenerative sacroilitis.

Jun 21, 2018

Hospitals, Surgeons Provide Insight into Purchasing Priorities

Executive Insights Industry Voices

The OMTEC 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure from public and private payors, bundled payments, value analysis committees and outpatient surgeries.

Jun 21, 2018

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

Company Updates Competitive Landscape

To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.

Jun 21, 2018

Study Validates NuVasive’s Porous PEEK Cohere

ORTHOFLASH Spine

Study results indicate that NuVasive's porous PEEK technology, used in the Cohere® cervical interbody fusion device, presents a clinically viable option to improve osseointegration and fusion.

Jun 20, 2018

DePuy Synthes Launches DYNACORD Suture

ORTHOFLASH Sports Medicine

DePuy Synthes Mitek Sports Medicine commenced limited U.S. launch of DYNACORD Suture. Full launch is slated for 3Q18.

Jun 20, 2018

Medtronic’s Kyphon Cement Cleared for Sacral Fracture

ORTHOFLASH Spine

Medtronic gained FDA 510(k) clearance for Kyphon HV-R Bone Cement for use in sacroplasty.

Jun 20, 2018

Anika Therapeutics Announces Top-Line Results from CINGAL Trial in Knee OA

Orthobiologics ORTHOFLASH

In the Phase III 16-02 clinical trial of Anika Therapeutics' CINGAL, statistically significant results in pain reduction were not demonstrated at the primary endpoint of 26 weeks.

Jun 20, 2018