EU Allows Notified Bodies to Conduct Audits Remotely
While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could...
Jan 26 2021,
T-FIX 3DSI Joint Fusion System Receives FDA 510(k) Clearance
8 Tips for Startups on Successful Execution
Orthopedic startups should follow these eight tips for successful business execution. ...
Jan 26 2021,
FDA 510(k) Recap: First Orthopedic Clearances
This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six...
Jan 25 2021,
FDA Releases AI Action Plan for Medical Devices
FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and...
Jan 25 2021,
Infographic: 3 Top Orthopedic Trends for 2021
As we consider 2021 trends, an increase in enabling technology adoption, procedure shifts to ASCs and M&A activity top the...
Jan 20 2021,
Precision ADM Appoints Pablo Batista as Vice President, Engineering and Operations
Precision ADM has its roots in the orthopedic medical device industry and has developed an Advanced Digital Manufacturing® process which...
Jan 12 2021,
ARCH Global Precision Acquires LISI Medical Jeropa
A subsidiary of LISI Medical, the Jeropa plant is a leading contract manufacturer of high-precision medical implants, instruments, and other...
Jan 12 2021,
3 Ways to Kickstart Your Professional Development in 2021
Members of BONEZONE’s Advisory Board offered advice for their orthopedic device company peers on advancing skillsets and knowledge. ...
Jan 12 2021,
Additive, AI, Digital Health Noted in FDA’s 2021 Science Report
FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and...
Jan 12 2021,
Sensors Gain Spotlight in 3 Recent Orthopedic Announcements
Stryker and Exactech acquired new technology, while Canary Medical received new funding. The three companies will utilize tools in joint...
Jan 12 2021,
Sydney University and GE Additive Partner to Drive Australian Manufacturing
The agreement will establish capabilities in metal additive manufacturing technology at the Sydney Manufacturing Hub, a space for training specialists...
Jan 11 2021,
Packaging Provider Nelipak Appoints Pat Chambliss as Chief Executive Officer
Nelipak Healthcare Packaging is a global manufacturer of custom-designed rigid and flexible healthcare packaging used for Class II and Class...
Jan 11 2021,
4D Biomaterials Furthers Commercialization for 3D Tissue Scaffolds
The company is developing polycarbonate-based resins, which can be formed into materials that have good shape memory and promising tissue-healing...
Jan 11 2021,
FDA Adds Bone Screws and Spine Plates to Alternative 510(k) Pathway
The voluntary Safety and Performance Based Pathway allows manufacturers with moderate-risk devices to meet specific performance criteria instead of testing...
Jan 11 2021,
New AR Glasses Used in Holographically-Navigated Spine Surgery
A university startup teamed with Microsoft to build augmented reality technology for spinal surgery. The first procedure launched a randomized...
Jan 11 2021,