St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI ™ Pacemaker and the Tendril MRI ™ lead.
Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration StaffJune 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
This draft guidance document provides draft recommendations for complying with special controls being proposed to support reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed...
Available immediately are 6 new analog Z-Drive models with increased current output of 60A peak and 30A continuous designed with the same footprint and pin functionality as the previous 40A versions. These new servo drives provide 50% more power in the same space, making upgrades in power output a simple drop-in replacement.
Galil Motion Control has announced the latest product in their RIO Pocket PLC Series. The new RIO-47300 includes more I/O, screw terminals and two Ethernet ports which allow management of an unlimited number of inputs and outputs without an external Ethernet switch.
At the 2013 International Forum on Design for Manufacture and Assembly (DFMA), Boothroyd Dewhurst announced the release of its DFA Product Simplification software, Version 10. The Design for Assembly software has an improved user interface for speed and ease of use, and helps manufacturers develop more streamlined and profitable products.
Multifunctional devices such as tablets, ultrabooks and even smartphones need high brightness levels and good color rendering without draining the batteries too quickly. The new MicroSideled 3806 from Osram Opto Semiconductors is designed specifically to meet these requirements.
CEA-Leti and nine partners in the NEPHRON+ project are developing an artificial kidney that would provide a major improvement in treating patients with chronic kidney failure. The goal is a next-generation, integrated system that allows real-time, continuous, multiparametric monitoring of the patient and the device via sensors developed by Leti and its partners.
In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
There have been reports of issues and lawsuits from procedures gone wrong when a robotic surgical system was used. Yes, there have been issues and they do need to be addressed, however, abandoning robotic surgical systems is not the answer. In fact, it would be a complete mistake.
Soon, women in Europe may be taking a new look at one of the world’s oldest forms of contraception. European regulators have granted the single-size SILCS Diaphragm a CE marking, allowing the product to be sold throughout Europe. The launch is also an important step toward expanding nonhormonal contraception options for women worldwide.
Axio Biosolutions Private Limited, a medical device designer and manufacturer company is proud to announce that it has obtained the European Union Class III Medical Device CE mark approval for its range of Emergency Haemostatic Dressing - AXIOSTAT. The CE mark designation will allow AXIOSTAT to be sold in the European Union and other countries.
Tangent Medical, an innovator in IV therapy products and creator of the NovaCath Integrated IV Catheter System, announced today its commercial product launch and start to clinical evaluations in several healthcare facilities across the U.S. The commercialization of this product is the first significant advancement in the IV catheter market in more than a decade.
Middle Peak Medical, a development-stage medical device company that will commercialize a novel technology for treating mitral valve disease, has raised $8.5M in a Series A financing. The round was co-led by healthcare investment specialists Wellington Partners and Seventure Partners, along with seed investor High-Tech Gründerfonds Management GmbH (HTGF).
Scientists in the US have developed a novel vaccination method that uses tiny gold particles to mimic a virus and carry specific proteins to the body’s specialist immune cells. The technique differs from the traditional approach of using dead or inactive viruses as a vaccine and was demonstrated in the lab using a specific protein that sits on the surface of the respiratory syncytial virus (RSV).