International
-
Medical Device Equivalence Requirements Strengthened under the EU MDR
This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20
-
3-D Printing/Additive Mfg.
Russian Scientists Develop Novel Ceramic Bone Implant Manufacturing Method
Designing and manufacturing complex-shaped ceramic bone implants with a controllable porous structure.Skolkovo Institute of Science and Technology 11.13.20
-
Biologics
i-FACTOR + Matrix Launches in Canada
Becomes the first market to offer the i-FACTOR+ MATRIX.Cerapedics 11.05.20
-
Tegra Medical Expands Globally
Extends its end-to-end contract manufacturing services to Europe and Asia.Tegra Medical 10.26.20
-
3-D Printing/Additive Mfg. | Bracing/Prosthetics
Novel 3D Printed Non-Metallic Self-Locking Prosthetic Arm Developed
More comfortable, flexible, and 20 percent cheaper than a conventional prosthesis.Singapore University of Technology and Design 10.26.20
-
Coatings/Surface Modification
Coating Implants with 'Artificial Bone' to Prevent Inflammation
Superior coating performance achieved compared to existing clinical products.National Research Council of Science & Technology 10.23.20
-
Imaging | Spine/Neurology
Eyeglass-Attached Display Provides Fluoroscopic Guidance During Spine Surgery
Device allowed the surgeon to focus on operative tasks more efficiently.Journal of Neurosurgery Publishing Group 10.14.20
-
Spine/Neurology
Intralink-Spine Inc. Adds Clinical Sites in Australia
Company is expanding the clinical trial for its Réjuve medical device, designed to treat low back pain.Business Wire 09.16.20
-
MEDICA and COMPAMED 2020 Go Virtual
Events to be launched as 'virtual.MEDICA' and 'virtual.COMPAMED' with three focal areas.Messe Düsseldorf 09.15.20
-
Large Joint
Smith+Nephew Launches NOVOSTITCH PRO Meniscal Repair System in Europe
Vertically placed, circumferential sutures expand possibilities of meniscal repair.PR Newswire 09.02.20
-
Extremities | Materials
Eggshell-Based Surgical Material for Skull Injuries
Eggshell-derived bioceramic provides increased implant strength and biointegration.The National University of Science and Technology MISiS 08.13.20
-
U.S. Commercial Service Launches Trade Show Booth Staffing Program
Hire someone to staff your booth at upcoming trade fairs.U.S. Commercial Service 08.03.20
-
Imaging | Spine/Neurology
7D Surgical Earns CE Mark for Machine Vision Image-Guided Spine Surgery
The platform is the only spine navigation system to offer true segmental registration, according to the company.PR Newswire 07.15.20
-
Bracing/Prosthetics
Orthotics Breakthrough Helps Children with Cerebral Palsy Walk and Play
Can decrease the energy they use to walk by as much as 33 percent.Staffordshire University 06.10.20
-
Spine/Neurology
Nevro Earns CE Mark for Senza Omnia Spinal Cord Stimulation
Designed to provide physicians maximum versatility to manage chronic pain.PR Newswire 05.14.20
-
MDR Delay Official; Industry Urges Push Back of IVDR
European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.MedTech Europe 04.24.20
-
Biologics
Biocomposites' STIMULAN Earns CE Mark
First calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue.PR Newswire 04.23.20
-
Spine/Neurology
'Smart' Chair Will Correct Students' Posture
The chair is equipped with special sensors that detect posture and forewarn when people are sitting incorrectly.South Ural State University 01.17.20
-
3-D Printing/Additive Mfg. | Biocompatibility & Testing
LimaCorporate Opens 3D Printing Center & Advanced Laboratory for Testing and Analysis
Both will strengthen the collaboration between all departments and surgeons.PR Newswire 01.17.20
-
Bracing/Prosthetics
First 3D-Printed, Sensor-Operated Prosthetic Arm for Toddlers
UK team built a prototype of a myoelectric (muscle-stimulated) prosthesis for children under two.University of Lincoln 01.14.20
