|By PR Newswire||
|January 8, 2014 06:00 AM EST||
KIBBUTZ HAMA'APIL, Israel, January 8, 2014 /PRNewswire/ --
The acWire Guidewire is intended to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional cardiovascular procedures. The acWire device is specifically intended for implantation plane acquisition, during Trans-Catheter Aortic-Valve Implantation (TAVI) procedures.
MediValve, Ltd., today announced that the company has received European pre-market clearance for the acWire Guidewire, following review of a Technical File submission by the Institute for Testing and Certification, Inc ("ITC"). The European pre-market clearance completes the Conformité Européenne, or "European Conformity" ("CE") registration process. The acWire is specifically intended for implantation plane acquisition, during Trans-Catheter Aortic-Valve Implantation (TAVI) procedures, using fluoroscopic imaging.
Previously, MediValve completed filing a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for the acWire.
Assaf Klein, Chief Executive Officer for MediValve commented, "We are thrilled to have reached the milestone of receiving CE pre-market clearance of the acWire. We anticipate significant clinical interest for this innovative technology. This is the first in a series of regulatory applications while we continue our development of several additional acWire products."
Gad Keren, MD, Chairman of the Department of Cardiology, Tel-Aviv University's Sackler School of Medicine, commented, "Accurate positioning of interventional medical devices within the cardiovascular system is critical to patient safety and successful clinical outcomes. The acWire technology now being developed by MediValve holds the promise of addressing both critical needs. With an aging population world-wide and an increasing incidence of cardiovascular interventions, the clinical community will look for solutions that increase patient safety and facilitate uniform and consistent clinical results. I look forward to acWire entering the clinic."
About Gad Keren, MD
Gad Keren, MD, has been Professor of Cardiology at Tel-Aviv University's Sackler School of Medicine since 1994. Prof. Keren serves as Head of the Department of Cardiology at the Tel Aviv Medical Center. He served as Medical Director of B-Balloon Ltd., in addition to several other innovative medical device companies. Prof. Keren has held the Chaim Sheba Chair of Cardiology at Tel Aviv University since 2005. Prof. Keren was a research fellow at the National Institute of Health in 1989 and 1990. Prof. Keren has co-authored over 200 original articles, numerous case reports and review articles. He has written numerous patents in the field of cardiovascular therapeutics.
About the MediValve, Ltd., acWire™ Guidewire
The MediValve acWire™ Guidewire is a single-use, fully disposable medical device utilizing innovative shape-memory alloy technology intended to enable identification of cardiovascular structures utilizing existing imaging methods. Use of acWire employs methods and techniques currently utilized by interventional cardiologists to access the cardiovascular system. Once directed to a selected cardiovascular location, acWire is deformable under fluoroscopy to identify a desired specific anatomical landmark for subsequent therapeutic treatment by the clinician. acWire is designed to facilitate the accurate placement and alignment of medical devices in the cardiovascular system during diagnostic and interventional procedures.
About the CE Mark
The CE mark (Conformité Européenne, meaning "European Conformity," formerly EC mark) according to the European Medical Directive (MDD), is a mandatory conformity mark for medical devices placed on the market in the European Economic Area (EEA). With the CE marking on a medical device, the manufacturer ensures that the product conforms to the essential requirements of the applicable EC medical device directives.
About MediValve Ltd.
MediValve, Ltd., was founded in 2010, it is a portfolio company of The Trendlines Group (http://www.trendlines.com). MediValve is developing the acWire Guidewire to facilitate the accurate placement of medical devices in the cardiovascular system during diagnostic and interventional procedures.
The Trendlines Group (http://www.trendlines.com) creates and develops companies to improve the human condition, investing in medical device and agricultural technology companies. The Trendlines Group owns two Israel-based business incubators: Trendlines Medical, which invests medical device companies; and Trendlines Agtech, which focuses on agricultural technologies. The Trendlines portfolio includes 60 companies, with 15 that have already brought products to market.
1. This product is not approved for sale in the US.
2. Patents pending.
3. Dr. Keren is a member of the MediValve Board of Directors and the Chairman of the Medical Advisory Board
For Further Information, Contact:
Bill Edelman, Chairman of the Board
SOURCE MediValve, Ltd.
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 28, 2017 02:30 AM EDT Reads: 1,349
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Apr. 28, 2017 02:30 AM EDT Reads: 746
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
Apr. 28, 2017 01:15 AM EDT Reads: 9,250
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Apr. 28, 2017 01:15 AM EDT Reads: 8,958
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Apr. 28, 2017 12:45 AM EDT Reads: 1,668
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Apr. 28, 2017 12:15 AM EDT Reads: 1,364
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Apr. 28, 2017 12:15 AM EDT Reads: 807
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 28, 2017 12:00 AM EDT Reads: 16,322
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Apr. 27, 2017 11:30 PM EDT Reads: 2,299
Grape Up is a software company, specialized in cloud native application development and professional services related to Cloud Foundry PaaS. With five expert teams that operate in various sectors of the market across the USA and Europe, we work with a variety of customers from emerging startups to Fortune 1000 companies.
Apr. 27, 2017 10:45 PM EDT Reads: 2,428
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Apr. 27, 2017 10:30 PM EDT Reads: 2,451
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Apr. 27, 2017 10:30 PM EDT Reads: 1,298
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Apr. 27, 2017 10:15 PM EDT Reads: 1,471
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 27, 2017 10:15 PM EDT Reads: 2,658
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Apr. 27, 2017 10:15 PM EDT Reads: 9,241