MedTech is Unprepared for MDR Deadlines, Survey Highlights
MedTech Europe concluded there's an urgent need for immediate action to help keep needed medical devices available in Europe....
Jul 22 2022,
Competitive Landscape
So, You Think You Have a Novel Device? Here’s What FDA Says.
Got a potentially noteworthy or novel device? Here are some tips to help determine the best regulatory submission pathway....
Jul 22 2022,
Onkos Surgical Pelvic Reconstruction System Gains FDA 510(k) Clearance
The company expanded its portfolio of musculoskeletal oncology and complex orthopedic solutions to include conditions of the pelvis....
Jul 20 2022,
T-FIX 3DSI Joint Fusion System Receives FDA 510(k) Clearance
The T-FIX 3DSI Joint Fusion System is the first of many from Cutting Edge Spine to implement proprietary trabecular fixation...
Jul 20 2022,
Medtronic Receives FDA Clearance for Next-gen UNiD Spine Analyzer
Medtronic continues to evolve the UNiD platform to help surgeons plan procedures and predict post-operative spinal compensation....
Jul 18 2022,
Centinel Spine Receives FDA Approval for Additional prodisc Devices
The company continues to enroll for a two-level prospective, randomized, multi-centered clinical study for prodisc C Vivo and prodisc C...
Jul 18 2022,
New MedTech Accelerator Launches in Warsaw, Indiana
The new studio, launched by the Kosciusko Economic Development Corporation, aims to support area entrepreneurs....
Jul 13 2022,
Acumed Acquires ExsoMed to Enhance Upper Extremity Solutions Portfolio
The addition of ExsoMed enhances Acumed’s comprehensive portfolio of upper extremity solutions for simple to complex injuries....
Jul 12 2022,
Enovis Completes Acquisition of Insight Medical Systems
The transaction expands the enabling technologies platform for Enovis’ reconstructive portfolio with AR surgical guidance technology....
Jul 12 2022,
Understanding Process Validation Requirements for Orthopedic Products
Advice on how to Make Sense of the IQ/OQ/PQ alphabet soup....
Jul 11 2022,
Executives Talk About the Future of Orthopedics
Experts from companies like Enovis and ZimVie spoke to OMTEC attendees about their outlooks on the future of ASCs, new...
Jun 30 2022,
Stryker Launches EasyFuse3 Dynamic Compression for Foot and Ankle
The staple system is designed to decrease surgical complexity, provide strong dynamic-compression implants and reduce waste....
Jun 29 2022,
Royal Biologics Launches MAXX-BMC Bone Marrow System
MAXX-BMC is a bone marrow aspirate concentration system that provides users an optimal sample of concentrated bone marrow aspirate....
Jun 29 2022,
Full Launch of SeaSpine WaveForm TLIF Oblique
WaveForm TO was designed for both posterior lumbar interbody fusion and transforaminal lumbar interbody fusion procedures....
Jun 29 2022,
OssDsign Launches Cranial PSI in Japan
OssDsign announced it completed its first sales of OssDsign Cranial PSI in Japan. The launch marks an important strategic milestone....
Jun 29 2022,