Are You Capturing the Right Inspection Information?
By recording actual results, instead of pass/fail, you can better investigate failures that may occur in production/post-production. This approach also...
Feb 19 2018,
Competitive Landscape
Episurf Medical to Launch Custom Ankle Implants Using Episealer® Technology
The Stockholm, Sweden-based company is preparing a 2Q18 launch of patient-specific Episealer® implants to treat osteochondral lesions of the talus...
Feb 19 2018,
Why You Should Stop Saying “Volume to Value” in Healthcare
"Our goal should continue to be to improve outcomes and experience for the greatest number of patients possible by providing...
Feb 19 2018,
Supplier M&A on the Rise
Over an eight-year span, the gap between the number of OEM transactions versus those in the supplier space was its...
Feb 01 2018,
Smith & Nephew’s eCAP Shows 97% Decrease in Readmission Rates
The initiative is designed to mitigate risk associated with readmissions in value-based healthcare reimbursement models....
Feb 01 2018,
FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections
The rule amends that inspections will be risk-based, not biennial....
Feb 01 2018,
UDI: Is Your System Ready for Scale?
UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance...
Jan 31 2018,
Articulus Bio Gains Funding, Focusing on Total Ankle Replacement
The company is addressing the issue of wear debris and seeks capital to collect data on sub-assembly components of its...
Jan 19 2018,
RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology
RTI Surgical is expanding its spine fusion portfolio with its recent acquisition of Zyga Technology, developer of the SImmetry® Sacroiliac Joint Fusion...
Jan 19 2018,
FDA Issues First De Novo Clearance Under Orthopaedic Panel
IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. ...
Jan 18 2018,
Zimmer Biomet Appoints Bryan Hanson as President and CEO
Hanson joins ZBH from Medtronic, where he served as Executive Vice President and President of the Minimally Invasive Therapies Group....
Jan 17 2018,
The Brazilian Market: A Regulatory Overview for Orthopaedic Products
Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating...
Jan 05 2018,
Be Prepared When Suppliers are Acquired
With the recent M&A activity in the supplier space, all OEMs should be prepared in the event an important supplier...
Jan 05 2018,
FDA Releases Priorities for 2018
Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices....
Jan 05 2018,
Forward Momentum Continues in Artificial Discs
We highlight recent clinical trial results, a procedural milestone and a device launch....
Dec 08 2017,