ConforMIS Update on iTotal Hip FDA Submission
ConforMIS withdrew its FDA 510(k) application for the iTotal Hip device, and plans to submit a new application in 2H16....
Apr 04, 2016,
ConforMIS Update on iTotal Hip FDA Submission
Zyga Enrolls First Patients in Expanded Clinical Study on Sacroiliac Joint Fusion
Zyga Technology enrolled the 1st 4 patients in an expanded EVoluSIon Clinical Study evaluating long-term fusion and pain reduction in patients...
Apr 04, 2016, Julie Vetalice
Vivex Biomedical and Arthrex Enter into Long Term Agreement
Vivex Biomedical and Arthrex signed a new multi-year agreement expanding the breadth of Vivex’s products for Arthrex’s distribution....
Mar 31, 2016, Julie Vetalice
Renovis Surgical Receives FDA Clearance of Tesera SC Cervical Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system....
Mar 31, 2016, Julie Vetalice
Extremity Medical Receives FDA 510(k) Clearance for Align Ankle Fusion System
Extremity Medical received FDA 510(k) clearance to market the Align Ankle Fusion System™. Initial launch is slated for mid-April 2016. ...
Mar 30, 2016, Julie Vetalice
Clinical Studies Compare ConforMIS iTotal CR Knee to Off-the-shelf Devices
Study results demonstrated that patients implanted with ConforMIS’ iTotal® CR customized total knee exhibited more natural knee kinematics vs. those...
Mar 30, 2016, Julie Vetalice
Independent Peer-Reviewed 5-Year Follow-Up: 2-Level Cervical Disc Replacement vs. ACDF
Results from 5-year clinical study comparing cervical total disc replacement (LDR’s Mobi-C) with anterior discectomy and fusion to treat 2-level degenerative disc...
Mar 30, 2016, Julie Vetalice
Xtant Medical Receives FDA Clearance of Xspan Laminoplasty Fixation System
Xtant Medical received FDA 510(k) clearance to market the Xspan™ Laminoplasty Fixation system. Initial limited launch is slated for 2Q16. ...
Mar 30, 2016, Julie Vetalice
Results from 6-month ActiPatch Product Observation Study
Results from a 6-month study observing BioElectronics’ ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for...
Mar 29, 2016, Julie Vetalice
Anika Therapeutics Obtains CE Mark Approval for Cingal to Treat Knee OA Pain
Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain. ...
Mar 29, 2016, Julie Vetalice
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