NASS Conversations Reaffirm Focus on Additive, Computer-Assisted Surgery, Materials
The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials...
Oct 05 2018,
Competitive Landscape
Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights
Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we...
Oct 05 2018,
Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning
Recent updates to standards and regulatory guidance have made sterilization processes more complex....
Oct 05 2018,
11 Arthroscopy/Soft Tissue Repair Companies Worth Watching
We looked at funding, patent and trial/study announcements from January 2017 to June 2018 to see whose initiatives are making...
Oct 04 2018,
How to Respond to FDA Inspection Observations, Even Those You Dispute
Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are...
Oct 04 2018,
b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip
The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing....
Sep 26 2018,
Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive
Medtronic, DePuy Synthes, Stryker and Globus Medical–four of the five largest spine companies ranked by revenue–announced acquisitions in the last...
Sep 24 2018,
25 Considerations for Companies Seeking Clarity in Design Controls
OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices...
Sep 24 2018,
Effective Supplier Scorecards Rely on Identifying Key Metrics, Data, Inputs
The correct metrics for your scorecard can include elements of quality, on-time delivery, cost vs. value, and can yield actionable...
Sep 24 2018,
ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial
Company founder Martha Murray, M.D., pioneered Bridge-Enhanced® ACL Repair (BEAR) technology, a proprietary bio-engineered sponge used as a bridging scaffold...
Sep 21 2018,
NASS Preview: 14 Spine Products That Caught Our Attention
Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations...
Sep 10 2018,
Musculoskeletal New Ventures Conference Offers Insights on Funding, Startups
Orthopaedic professionals can expect to hear about technologies being commercialized by 22 companies along with insight from long-term investors during...
Sep 07 2018,
Wright Medical’s Acquisition of Cartiva Offers Boost for Lower Extremity Business
Cartiva’s Synthetic Cartilage Implant is used to treat arthritis in the great toe. Wright’s $435MM purchase of the technology (expected...
Sep 07 2018,
Stryker Moves to Strengthen Spine Business with $1.4 Billion Purchase of K2M
K2M’s innovative technology platform will add a suite of complex spine solutions to Stryker’s core spine portfolio; K2M’s consistent support...
Sep 07 2018,
510(k) Recap: New Products from Companies You Know
We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and...
Aug 21 2018,