Zimmer Biomet Responds to FDA Form 483
Zimmer Biomet published a response to the Form 483 issued by FDA in April 2018, related to inspectional observations at the...
Jun 26, 2018,
Zimmer Biomet Responds to FDA Form 483
Public Orthopaedic Companies: 1Q18 Revenue
Alongside their 1Q18 results, numerous players reaffirmed or updated their full-year revenue guidance. Globus Medical increased its numbers based on...
Jun 21, 2018,
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...
Jun 21, 2018,
Hospitals, Surgeons Provide Insight into Purchasing Priorities
The OMTEC 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure...
Jun 21, 2018,
FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances
To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their...
Jun 21, 2018,
Study Validates NuVasive’s Porous PEEK Cohere
Study results indicate that NuVasive's porous PEEK technology, used in the Cohere® cervical interbody fusion device, presents a clinically viable option to...
Jun 20, 2018,
DePuy Synthes Launches DYNACORD Suture
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
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
In the Phase III 16-02 clinical trial of Anika Therapeutics' CINGAL, statistically significant results in pain reduction were not demonstrated...
Jun 20, 2018,
Arthrosurface Trial Results with PF Wave Implant
Five-year midterm clinical study results reconfirmed joint preservation in patellofemoral surgery using Arthrosurface's PF Wave implant....
Jun 19, 2018,
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