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.
Approval/Clearance
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.
First US Patient For Endosense TactiCath® Quartz Contact-Force Sensing Ablation Catheter
Contact-force sensing cardiac ablation for arrhythmia treatment has taken a step forward with the announcement by Endosense that its newest iteration device has been used in a US patient for the first time. The device has been on general release in Europe since last June.
FDA Nod For Ethicon Endo’s ENSEAL® G2 Articulating Tissue Sealer
Ethicon Endo-Surgery says its ENSEAL® advanced bipolar devices are strong on sealing, yet gentle on tissue. And now with a new Articulating iteration these benefits can be exploited in the most difficult-to-access anatomies.
Medtronic’s Newly CE Marked Evera® ICD Claims Enhanced Longevity, Shock Reduction And Patient Comfort
We’re always on the look-out for technologies that nudge the state of play forward. Medtronic’s next-generation Evera® ICDs offer patients proven treatment performance, increased longevity, improved comfort and are now CE marked.
Digirad’s Ergo™ Imaging System Sees Indications Extended
Digirad’s highly ergonomic ergo Imaging System has seen its utility extended to more applications with a new FDA 510(k) clearance. ergo can now be used in nuclear medicine, surgery and women’s health.
CE Mark For Direct Flow’s Novel Polymer-Ring-Design Transcatheter Aortic Heart Valve System
California’s Direct Flow Medical®, Inc., has gained CE Mark approval for its distinctive transcatheter aortic heart valve with a metal-free frame and low-profile transfemoral delivery system. The system uses a twin-donut effect fillable ring to optimise positioning.
CE Mark For Next Generation Ultrasound Renal Denervation System
VHS/Betamax/Bluetooth/DVD/Ultrasound/RF? It seems like we’re approaching a technology stand-off in the growing world of renal denervation. Ultrasound advocates claim advantages in reaching the nerves RF can only reach by heating things up a bit too much.
FDA Clears Novel Minimal Access Distal Radius Fracture System
We’re loving the number of really clever devices coming before us at the moment. This really smart device for performing distal radius fracture fixation in a minimally invasive manner is a case in point.
FDA Clears TraceIT Hydrogel Tissue Marker, Visible On CT, MR and Ultrasound.
Augmenix, Inc. has received FDA 510(k) clearance to market its TraceIT Tissue Marker, an absorbable tissue marker visible under CT, MR, cone beam and ultrasound imaging modalities.