Yet again it’s registry data that has provoked a recall, this time of DePuy’s erstwhile Adept modular femoral component, which forms part of the all metal system originally sourced from Finsbury Orthopaedics Ltd.
Regulatory
FDA Approval For “Bionic Eye”
Second Sight Medical’s Argus® II Retinal Prosthesis System is the first approved bionic eye in the US with life-changing potential for the treatment of blindness due to retinitis pigmentosa
FDA Approval Of Aorfix AAA Graft Opens Treatment For Patients With Neck Angulation Of Up To 90 Degrees
Lombard Medical Technologies PLC has announced that its Aorfix™ endovascular stent graft has been approved for commercial sale in the U.S. by the FDA. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees.
CE Mark For ApiFix’s Ingenious Yet Simple Scoliosis System
What an elegant system this is. ApiFix’s newly CE marked device minimises surgical trauma for scoliosis correction in adolescents, and then works in combination with physiotherapy to incrementally correct a curvature over time. Quite a brilliant idea.
FDA 510(k) Clearance for Freedom Meditech’s ClearPath DS-120™ Ophthalmic Biomicroscope
Freedom Meditech’s clever lens-fluorescence biomicroscope is a non-invasive ophthalmic diagnostic device that obvates the need for dilation drops and claims greater precision than current standard of care devices.
CE-mark And Launch Of CERAMENT™|G The First Injectable Gentamicin Eluting Bone Substitute To Promote And Protect Bone Healing In Osteomyelitis
Scandinavian medtech company Bonesupport is an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery. The company has announced that the next generation product of the CERAMENT™ family, CERAMENT™|G has received CE-mark.
FDA Nod For Medtronic’s New MRI-Friendly Pacing System
Medtronic has gained FDA approval and will commence U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The system is Medtronic’s second-generation MR-Conditional pacemaker and is the first to combine the most advanced pacing technology with proven MRI access.
FDA Class I Recall For St. Jude’s Amplatzer™ TorqVue FX Delivery System
St.Jude’s Amplatzer PFO device has its own dedicated delivery system, called Amplatzer “TorqVue”. It seems there is a problem with the core wire on certain batches, all of which are now subject to an FDA class I recall.
CE Mark For Boston’s Promus PREMIER™ Everolimus-Eluting Platinum Chromium Stent System
Boston Scientific Corporation has received CE Mark approval for the Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, the company’s next-generation durable polymer drug-eluting stent technology.
FDA Clears Zoll’s First Fully Automatic Defibrillator
The FDA clearance of Zoll’s AED Plus® external defibrillator is the first time the company’s Real CPR Help®, proprietary feedback technology has been made available in a fully automatic AED.
Newly Cleared Extremity Scanner Finds The Most Subtle Fractures
Planmed Verity® is designed to find subtle extremity fractures at the first visit to the clinic – fractures that have been the most commonly missed using only 2D radiographs. Now the device is available for sale in USA too.
FDA PMA For VASCADE™ Vascular Closure System
Cardiva Medical, Inc. has gained an FDA Premarket Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression for patients undergoing percutaneous procedures through the femoral artery.
FDA Clears Smith Medical’s CADD®-Solis VIP Ambulatory Infusion System
Smiths Medical has announced FDA 510(k) clearance for its CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software. This multi-therapy pump includes applications from TPN to chemotherapy, antibiotics, hydration and pain management with intuitive, easy to use navigation and features inbuilt safety measures.
FDA Clears Sculptor Robotic Guidance Arm™ For Uni Knee Surgery
Stanmore Implants has received 510(k) clearance from the US FDA to market its Sculptor Robotic Guidance Arm™ for precision implant placement in unicompartmental knee surgery, also known as partial knee resurfacing.
First FDA Spinal 510(K) Clearance For Device Using Evonik’s VESTAKEEP® PEEK
The manufacturer of a proprietary brand of PEEK material is excited that its material has gained the FDA nod in the form of a spinal implant, in itself a good rubber stamp for the technology.
German Reimbursement For Delcath’s Chemosat Liver Cancer Drug Delivery System
Delcath Systems, Inc. has announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride.