Dialysis product company NxStage® Medical, Inc. has announced CE Mark approval for new high flow capabilities with the NxStage System One™. With this approval, the Company expects to bring this advancement to customers in countries that recognize the CE Mark approval process later this year.
Technology
Patent Portfolio Growing For Direct Flow Medical’s Innovative TAVI System
Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, has announced it has been awarded two new patents for its clever TAVI system. One in Japan, one in U.S.
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.
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.
Plastic/Stem Cell Hybrid Offers Bone Replacement Potential
Collaborative research performed between the Universities of Edinburgh and Southampton has resulted in a material that combines a plastic scaffold with the potential for stem cell regeneration of bone. It’s hoped the development may result in an expanded ability to repair bone in the most traumatic fracture cases involving bone loss.
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.
New Biochip Technology Signals Revolution In Point-Of-Care Diagnosis
Collaborative venture OJ Bio has developed a biochip that can produce diagnoses within 10 minutes with 100% specificity and no false positives. Combined with smartphone technology this opens the door to global improvements in healthcare provision across a range of diseases that may ultimately include HIV.
Read Medlatest’s Weekly “View From The Med” Now
In the title of this week’s piece we ask whether patients will ever be specifiying the devices that will be used on them. We rather hope they won’t, but then again a bit more information wouldn’t go amiss. After all, who’s body is it?
Automating Hospital Systems Will Save Lives And Millions Says GE
GE Global Research says its scientists will soon begin a groundbreaking project designed to transform the way hospitals manage and track their thousands of surgical tools.
Tactile Control, Precise Cuts And Short Learning Curve For Misonix BoneScalpel™ Says New Paper
The Misonix® BoneScalpel Ultrasonic Bone Cutter has cropped up in a clinical paper, so why wouldn’t the manufacturer point us at the comments, especially when they say the device offers a good solution for head and neck surgeons when harvesting bone.
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.
Cook Launches Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath
The only FDA approved ureteral access sheath that has two options for placement is now available in the United States. The Flexor® Parallel™ Rapid Release™ Ureteral Access Sheath allows urologists to use a single wire guide that functions as both a working wire and a safety wire.
AngioDynamics Expects Microsulis Microwave Ablation Acquisition Will Fuel 20% Annual Growth
Vascular device company AngioDynamics has exercised its option to purchase certain assets of Microsulis Medical Ltd. including a leading microwave ablation technology and its worldwide distribution rights.
New FDA Clearance Means You Can Now Capture Ophthalmoscope Images On Your iPhone
Diagnostic device company Welch Allyn, has received FDA 510(k) clearance to market its iExaminer™ iPhone compatible image capture system that allows healthcare providers to capture, store, send and retrieve images from the Welch Allyn PanOptic™ Ophthalmoscope using the iPhone® 4 or 4S.