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OBVIUS Robotics™ Receives U.S. FDA Breakthrough Device Designation for CERTA™ Access System for Central Venous Catheterization

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SUNRISE, Fla., Aug. 26, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its CERTA Access System for central venous catheterization (CVC).

Breakthrough Device Designation expedites the review of innovative technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To qualify for a Breakthrough Device Designation, a device technology must show that it has the potential to provide more effective treatment than current standards of care. The goal of the program is to help patients have more timely access to these medical devices by expediting their development, assessment and review.

CVC procedures are performed over 20 million times per year globally, yet outcomes are varied dependent upon the training and experience of the clinician. The procedure involves gaining access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring. Complication rates vary significantly, ranging from 4% to 11%, underscoring a significant need for better and more consistent outcomes.

“CVC procedures are required for a wide variety of conditions and patients for life saving care every single day,” said William Cohn, MD, Chief Medical Officer for Obvius Robotics. “Despite this fact, the procedure still has high complication rates and many health systems lack the expertise to reliably conduct the procedure on critically ill patients in a timely manner. A breakthrough is truly needed to improve care.” 

“The goal of Obvius Robotics is to become the new standard of care for CVC access,” said Russell Seiber, President and CEO of Obvius Robotics. “We are excited that the FDA has recognized the potential of the CERTA Access System to be a breakthrough for patients and clinicians. We believe this technology could improve care critical care settings by democratizing vascular access procedures.”

The CERTA Access System is not approved for clinical use at this time, but the company is currently preparing its submission to the FDA for market clearance leveraging the Breakthrough Devices Program.

About Obvius Robotics

Obvius Robotics is a privately held medical device company based in South Florida with clinical offices in the Center for Device Innovation at the Texas Medical Center, Houston, that is developing technology for image-guided access of structures within the body. The platform technology, the CERTA Access System, incorporates robotics and imaging to improve the accuracy, safety, and consistency of accessing targeted anatomy.  The company’s first clinical application is central venous catheter placement, a high-volume procedure in which CERTA has the potential to aid clinicians of varying levels of training and experience in safely and effectively achieving vascular access. Note: The CERTA Access System is not approved or cleared for use in patients in any geography at this time.

View original content to download multimedia:https://www.prnewswire.com/news-releases/obvius-robotics-receives-us-fda-breakthrough-device-designation-for-certa-access-system-for-central-venous-catheterization-302230420.html

SOURCE OBVIUS Robotics, Inc.

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Internet Society Report Highlights Challenges and Recommendations for Internet Connectivity in the Middle East

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WASHINGTON, Sept. 22, 2024 /PRNewswire/ — The Internet Society (ISOC), a global charitable organization advocating for an open, globally connected, and secure Internet, released a comprehensive report on the state of Internet connectivity across the Middle East and North Africa (MENA) region.

The report underscores Internet connectivity as a catalyst for economic growth and social development and how an increase in fixed broadband access has a direct impact on growing gross domestic product (GDP).

Key Findings:

Growth in Mobile and Fixed Broadband: Both mobile and fixed broadband connections have grown substantially from 2015 to 2021, particularly in Gulf States with advanced fiber-optic and 5G networks. However, deployment has been slower in other parts of the region, primarily due to infrastructure challenges and affordability issues.

Mobile Internet users increased from 130M to over 180M between 2016 and 2021, with Egypt, Tunisia, and Morocco showing the highest growth rates. Fixed broadband users rose from 17M to 29M in the same period, with Egypt leading the way. The Arab region lags behind other regions in fiber optic deployment, with stagnation in investment since 2018.

High-Income Countries: Significant progress in broadband infrastructure, especially in Gulf Cooperation Council (GCC) countries due to 5G rollout. High-income countries improved their Internet availability from 77.34 to 79.37, surpassing global averages.Low-Middle-Income Countries: Broadband has improved modestly, but challenges persist. Despite overall progress, a significant digital divide remains between high-income and low-middle-income countries, partly due to political and economic instability in some regions, such as Tunisia and Syria.

Infrastructure Challenges: There is a heavy reliance on European Internet Exchange Points for international Internet traffic, which results in slower speeds due to additional data hops.

Emerging Technologies: The report emphasizes the role of emerging technologies such as High-Throughput Satellites (HTS) and Low-Earth Orbit (LEO) satellites in bridging the connectivity gap. These technologies are crucial for expanding access to underserved rural areas.

Impact of COVID-19: The COVID-19 pandemic has adversely affected network performance and digital transformation plans, causing delays and disruptions in connectivity improvements.

Recommendations:

Policy and Regulation: The Internet Society advocates revising regulatory frameworks to accelerate infrastructure deployment. Key recommendations include enhancing spectrum policies, removing regulatory barriers, and fostering public-private partnerships to drive investment, competition, and support for small and medium enterprises.

Spectrum Availability: North African countries have limited spectrum compared to global averages, impacting network capacity and costs.Regulatory Frameworks: Enhance regulatory frameworks to foster investment, encourage spectrum and infrastructure sharing, and support new technologies like HTS and LEO satellites.

Collaboration and Investment: Promote public-private partnerships and update national broadband plans to improve infrastructure and connectivity.

Digital Skills and Literacy: Addressing digital skills and literacy is crucial for maximizing the benefits of Internet connectivity. The report calls for more affordable, relevant, and inclusive education and training programs to build a digital workforce.

Local Internet Exchange Points (IXPs): The report stresses the importance of establishing and upgrading IXPs to enhance local Internet traffic, reduce costs, and improve service quality. Governments are encouraged to support IXPs by providing resources and facilitating network interconnections.

“The Internet has become indispensable for many people, and its role in connecting people, fostering economic opportunities, and driving innovation is undeniable. The Arab region has made big leaps in the availability and adoption of the Internet in recent years; however, adoption rates are still low. We hope that governments will use our report to learn about the improvements that can be made in infrastructure deployment, affordability of service, market structure, and regulatory frameworks,” explains Nermine El Saadany, Regional Vice President for the Middle East for the Internet Society.

About the Internet Society
Founded by Internet pioneers, the Internet Society (ISOC) is a global charitable organization dedicated to ensuring the open development, evolution, and use of the Internet. Through a global community of chapters and members, the Internet Society collaborates with a wide range of groups to promote the technologies that keep the Internet safe and secure and advocates for policies that enable universal access. The Internet Society is also the organizational home of the Internet Engineering Task Force (IETF).

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View original content:https://www.prnewswire.co.uk/news-releases/internet-society-report-highlights-challenges-and-recommendations-for-internet-connectivity-in-the-middle-east-302251836.html

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Representatives from 57 countries, regions and 6 international organizations, are gathering in Suzhou.

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What important topics are they discussing about? Let’s find out!

BEIJING, Sept. 22, 2024 /PRNewswire/ — I’m Xiao Lin from National Immigration Administration. On September 9th, the first Sub-Forum on Migration Management Cooperation was successfully held. Representatives from all parties expressed their insights and appeals around the development and innovation of migration governance.

It was truly a content-rich event!

Why does the international community focus on the topic of “Migration Governance” so much?

At present, changes unseen in a century is unfolding at a faster pace. The situation in the wider world remains complex and fluid. However, peace, development, cooperation and win-win results are still an unstoppable historical trend. Migration governance is critical to economic development of individual countries, global security governance and international cultural and people-to-people exchanges. It has increasingly become a key issue in global governance.

Here are the key points:
At the forum, NIA made three commitments: implementing more open policies for the cross-border flow of people, more effective actions in the governance of transnational crimes and more extensive global cooperation in migration governance, injecting new impetus to opening up and development; At the same time, three initiatives have been put forward, [Original scene of the initiative] contributing China’s wisdom and solutions to global migration governance and further showcasing its image as an open, confident, secure, and thriving major power.

Representatives also made keynote speeches, sharing their migration governance policies, measures and experience, and providing their perspectives on regional and international migration governance.

Pooling wisdom for win-win results.

In a changing era, National Immigration Administration of China stands ready to work with all parties to promote global migration governance to a higher level and contribute more wisdom to world peace, development, prosperity and stability!

View original content to download multimedia:https://www.prnewswire.com/news-releases/representatives-from-57-countries-regions-and-6-international-organizations-are-gathering-in-suzhou-302254859.html

SOURCE National Immigration Administration

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Supreme Court Justice Michelle O’Bonsawin Joins Elementary Students for Live Virtual Q&A and Chapter One Storybook Reading on Sep. 24

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The Honourable Justice Michelle O’Bonsawin, the first Indigenous person appointed to the Supreme Court of Canada, will join elementary students in a live virtual Q&A on September 24, from 1:00-2:15 pm ET, following a reading of the children’s storybook, “Daanis the Judge.” This event is hosted by Chapter One, a children’s literacy charity, to commemorate the National Day for Truth and Reconciliation. Lawyer Victoria Perrie, writer of “Daanis the Judge,” will read aloud the inspiring story, which is based on Justice O’Bonsawin’s remarkable journey. Illustrator EJ Miller-Larson will join Justice O’Bonsawin and Perrie in a moderated Q&A session with over 1900 elementary students.

TORONTO, Sept. 21, 2024 /PRNewswire-PRWeb/ — The Honourable Justice Michelle O’Bonsawin, the first Indigenous person to be appointed to the Supreme Court of Canada, will join elementary students in a live virtual Q&A following a live online reading of the original children’s storybook “Daanis the Judge,” on September 24, from 1:00-2:15 pm ET. The event will be hosted by Chapter One to mark the National Day for Truth and Reconciliation. Chapter One is a children’s literacy charity that provides 1:1 high-impact reading tutoring and co-creates original storybooks with participating communities nationwide.

“I am very humbled and proud to be a part of the book, “Daanis the Judge.” My hope is that this book will inspire youth to dream big and know that anything is possible. I am evidence of that!” – Justice Michelle O’Bonsawin

Métis-Cree lawyer Victoria Perrie, who wrote “Daanis the Judge,” will lead the live reading. Students will ask questions during a moderated Q&A with Justice O’Bonsawin, Perrie, and illustrator EJ Miller-Larson, of the Fond du Lac Band and Oneida Nation.

“Daanis the Judge” was inspired by Justice O’Bonsawin’s trailblazing career. It tells the story of a young student, Daanis, who dreams of becoming a judge after learning about Justice O’Bonsawin’s achievements.

The story is part of Chapter One’s growing collection of original children’s e-storybooks, co-created with Indigenous writers, illustrators and communities. The e-storybooks celebrate Indigenous experiences and perspectives, and feature audio clips of Elders pronouncing foundational words in their communities’ first languages. All e-storybooks are provided for free through the Global Free Library.

About Chapter One

Chapter One (chapterone.org/ca) is a global nonprofit and registered Canadian charity that provides one-on-one early literacy tutoring programs to 2,300 children in eight provinces and territories across Canada. Its proven “short burst” high-impact tutoring approach—five-minute sessions, three to five times a week—is ideally suited to young children’s attention spans and aligns with the Science of Reading. In one of the largest randomized control trials conducted on early literacy instruction, researchers from Stanford University found that 7 out of 10 students receiving Chapter One high impact tutoring achieved phonics benchmarks by the end of Kindergarten, compared to 32% in the control group.

Children at risk of reading failure receive 1:1 reading support from trained, paid paraprofessional tutors through Chapter One’s online reading platform and custom software. Programs are delivered in-person and virtually in classrooms through agreements with schools and school boards, and at home on families’ smartphones, connecting struggling readers with individualized reading support—regardless of location and circumstance, even in some of the most geographically remote communities in Canada.

In addition to its tutoring programs, Chapter One collaborates with Indigenous communities to co-create children’s stories that represent the communities’ priorities and experiences and advance language revitalization efforts. The e-storybooks are provided for free online, as part of the Global Free Library.

Event details

The Live Virtual Q&A and Reading of “Daanis the Judge” with the Honourable Justice O’Bonsawin takes place on Tuesday, September 24, from 1:00-2:15 pm ET via Zoom. The event is open to elementary classes (Grades 1-6). Teachers/principals must register their classes in advance using this link.

Media Contact

Denise Orosa, Chapter One Canada, 1 4374224825, denise.orosa@chapterone.org, chapterone.org/ca

View original content to download multimedia:https://www.prweb.com/releases/supreme-court-justice-michelle-obonsawin-joins-elementary-students-for-live-virtual-qa-and-chapter-one-storybook-reading-on-sep-24-302254639.html

SOURCE Chapter One Canada

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