Tyber Medical, a developer of spine and orthopaedic devices, has received CE Mark approval for its TyPEEK, a titanium plasma sprayed PEEK interbody system. The highly differentiated proprietary titanium plasma sprayed TyPEEK offers ...
US-based Moirai Orthopaedics has obtained CE Mark approval for its new Pyrocarbon Implant Replacement (PIR) system, designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. The ...
StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system. ...
Tags: Stelkast, Total Knee System
The Orthopaedic Implant Company (OIC), a developer of orthopaedic implants, launched its clavicle plate solution, designed to meet the needs of virtually all fracture patterns of the clavicle. The set includes midshaft, neutral and distal ...
Biomet Orthopedics has announced the first clinical use of its Signature patient-specific glenoid instrumentation in the US, which is designed to improve placement for total and reverse shoulder arthroplasty. The Signature glenoid system ...
Tags: Biomet Orthopedics, Glenoid System
Advanced Bionics has obtained the US Food and Drug Administration (FDA) approval for its new Naída CI Q70 (Naída CI) sound processor which is now commercially available in the US. Advanced Bionics in collaboration with ...
Tags: Advanced Bionics, Sound Processor
HeartWare International has received the U.S. Food and Drug Administration (FDA) approval to enroll supplemental patient cohort for ENDURANCE, a pivotal destination therapy clinical study. HeartWare will enroll up to 286 patients ...
Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system. The system enables surgeons to plan the implant ...
Tags: Shoulder System, Surgical products
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...
Edwards Lifesciences has obtained the reimbursement for its Sapien XT transcatheter aortic valve implant from Japan's Central Social Insurance Medical Council (Chuikyo) after the recommendation made by the Japanese Ministry of Health, Labor ...
Tags: XT Valve, Edwards Lifesciences
CoAlign Innovations, a US-based medical device company, has received the US Food and Drug Administration (FDA) approval for its AccuLIF XL lateral expandable interbody fusion devices. The new AccuLIF interbody system utilizes low-profile ...
Respicardia, a US-based developer of implantable therapies, has announced the enrollment of the first patients in the pivotal trial to evaluate the remede system in patients with central sleep apnea (CSA). The Respicardia pivotal trial is ...
Tags: Respicardia, Patient Enrollment
Colombian researchers of EAFIT and CES University have developed a biocompatible skull implant based on tomography for patients with severe head injuries. This implant is claimed to be far less expensive than those in the US, by about 50% ...
RTI Surgical, a manufacturer of orthopaedic and other biologic implants, has launched Tritium Sternal Cable Plating (SCP) system for closing median sternotomies following open heart procedures. The device incorporates the advantages of ...
Tags: RTI Surgical, Cable Plating System
Symetis has announced its Acurate TA and Acurate TF TAVI systems have been successfully implanted in patients in Japan as part of a feasibility study to secure the Pharmaceutical and Device Agency's (PMDA) pre-market approval. Based on a ...
Tags: Symetis, TAVI Systems