Edwards' Sapien XT transcatheter aortic heart valve (Courtesy Edwards Lifesciences) Edwards Lifesciences Corp. (Irvine, CA) has announced both the FDA approval and the U.S. launch of its next-generation Sapien XT transcatheter aortic ...
Tags: Health, Medicine, heart valve
FDA's Circulatory System Devices Advisory Panel has submitted a unanimous approval recommendation for C.R. Bard's Lutonix Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) catheter. If FDA follows the recommendations ...
Tags: Health, Medicine, FDA, Certification
CareDx. which two weeks ago entered into an agreement to acquire ImmuMetrix Inc., has announced that it intends to make an initial public offering (IPO) of common stock with the intent of realizing $50 million. Brisbane, CA–based ...
As part of the ongoing process begun by the 2012 Medical Device User Fee Amendments (MDUFA III),FDA has released its Implementation Plan for Priority Recommendations. This plan is intended to improve the efficiency of the device submission ...
Covidien plc (Dublin, Ireland) has announced that FDA has approved its Apollo Onyx delivery microcatheter, the first detachable-tip microcatheter available in the United States. The new microcatheter is designed to mitigate the technical ...
Tags: Microcatheter, Health, Medicine
"This is the first time a global pharmaceutical has made the move to putting invisible, edible barcodes on medication." [Wu Xi PharmaTech & TruTag Technologies] WuXi PharmaTech is a pharmaceutical, biotechnology and medical device R&D ...
Stellar Technologies, a leading manufacturer of complex, ultra-precise components and assemblies for medical applications, announced today the completed addition of 10,000 square feet of new manufacturing space. The expansion includes a new ...
Two new reports from iData Research cover the US market for vascular access devices and the European markets for cardiac surgery and heart valve devices. The European interventional cardiology report covers markets for tissue heart ...
Tags: Medtech Markets, US market
Tokyo-based Mitsubishi Electric Corp has started shipping samples of new 1200V hybrid silicon carbide (SiC) power semiconductor modules for high-frequency switching applications. Featuring SiC diodes, the modules achieve high efficiency, ...
Tags: Mitsubishi Electric, SiC power modules, High-Frequency Switching
AccessClosure's Mynx Grip extravascular closure device (Courtesy AccessClosure Inc.) Dublin, OH–based Cardinal Health Inc. has announced that it has completed its acquisition of privately-held AccessClosure Inc. (Santa Clara, ...
Tags: Accessclosure Takeover, Cardinal
An FDA news release has announced that the agency has given de novo approval to the Deka Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram ...
Tags: Bionic Arm, medical device
Boyd Coatings Research Co., Inc. has announced the availability of six PTFE colors – all of which are created with the company's new, fully-validated and FDA-compliant, Zero PFOA PTFE formula. Colors include blue, black, green, white, ...
Tags: Coatings
The global antimicrobial coatings market is expected to reach $4,520.3 million by 2020, according to a new study by Grand View Research Inc. Growing demand for medical device coatings is expected to remain a key market driver over the next ...
Ryan Heniford, Business Development Director at Secant Medical,Ryan Heniford. His presentation will highlight Secant Medical's research and development in biomaterials and advanced textile structures for regenerative medicine applications. ...
Blood glucose test strips sold in these packages have been declared misbranded by FDA and should not be used. (Courtesy FDA) FDA has announced the recommendation that use of Shasta Technologies' GenStrip Glucose Test Strips be ...
Tags: FDA, Certification, Health, Medicine