The U.S. FDA issued a draft guidance for premarket applications for class II bone grafting devices, a policy that would supplement a guidance issued nearly two decades ago.
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
Bongenix LLC reported the issuing of its very first patent, in which a non-invasive bone stimulating method and device are described for treating injured or diseased bone tissue with electricity.
A new 3D printing technique has allowed University of Nottingham researchers to tailor-make artificial body parts and other medical devices that are both implantable and bacteria-resistant. The multi-materials manufactured in the study were also adapted to 3D printing technology that is able to offer devices that can better meet the need of the patient and minimize the surgeries led by device failure that increase the risk of infections.
Restor3d Inc. added a new dimension to its offerings with its merger with Kinos Medical Inc. The combination will increase Restor3d’s presence in the foot and ankle repair and replacement market by adding the Kinos Axiom total ankle system to its portfolio of 3D-printed implants using biomedical materials in a variety of applications.
The FDA has granted 510(k) clearance to Orthofix Medical Inc.’s Construx Mini Ti spacer system for anterior cervical discectomy and fusion (ACDF) procedures. Company documents claim the implant has an optimized porosity and pore size, which creates a 3D porous surface with the potential for bone ingrowth.
HONG KONG – Israel and U.S.-based Rsip Vision Ltd. unveiled an advanced joint segmentation tool to assist with the planning of revision arthroplasty and other orthopedic procedures for patients with pre-existing metal implants. The detailed, noninvasive artificial intelligence (AI)-based software module enables quick and accurate segmentation of different joints from CT scans of hips, knees, shoulder and spines.
PARIS – Solvay SA is partnering with Printerprezz Inc. to develop 3D printing technology using Selective Laser Sintering (SLS) for implants and other medical devices.
A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.
BOGOTA, Colombia – Ziptek Mexico, from Hermosillo, Mexico, is working to revolutionize the sutures market with an innovative product that is already making its way to the U.S. surgical orthopedic device market. Plans to expand across Latin America are progressing.
RSS
