Camber Spine FDA 510(k) Clearance for Siconus SI Joint Fixation
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
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
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
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
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
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
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
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
Retrospective Study: Spinal Elements’ Magnum+ ALIF Device With Ti-Bond Coating
Patients in a retrospective study of Spinal Elements’ Magnum+® ALIF device with Ti-Bond® coating demonstrated a 96% success rate, with subjects achieving solid arthrodesis at an average of 7.3 ± 2.3 months. Jan 18, 2017
New Durolane Agreement in Russia
Bioventus selected MEDSERVICE to distribute DUROLANE® single-injection joint fluid in Russia. Jan 17, 2017
