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HeartFlow Files for FDA Clearance of Next Generation Product Offering to Help Evaluate the Presence of Narrowings and Plaque in the Coronary Arteries

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2 years ago

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REDWOOD CITY, Calif., Dec. 13, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced it has submitted a 510k premarket application to the U.S. Food and Drug Administration (FDA) to add advanced anatomic assessment and plaque evaluation to the HeartFlow FFRct Analysis. The PreRead anatomic assessment will help identify the presence and location of narrowings or stenoses in the coronary arteries based on coronary computed tomography (CT) scans. The HeartFlow Plaque technology will provide plaque volume and characterize the type of plaque present. By adding the anatomic assessment and plaque evaluation to the physiological information currently provided by the HeartFlow Analysis, physicians will gain a more comprehensive understanding of a patient’s coronary disease burden and support efficient risk stratification of patients who may be at high risk of death from a heart attack.

“HeartFlow is committed to becoming an indispensable partner to physicians in delivering precision heart care by providing a broad portfolio of game-changing innovations that leverages our core deep learning technology,” said John H. Stevens, MD, President, CEO and Co-Founder, HeartFlow. “The FDA submission is an important step towards delivering a solution that we believe supports complete cardiovascular care by providing clinicians with advanced insights about anatomy, physiology and plaque for their patients with coronary artery disease.”

PreRead is designed to provide a rich anatomic assessment of each coronary CT that, when considered by physicians in conjunction with other patient clinical information, helps physicians to quickly identify where coronary disease is present and understand the severity of the narrowing. The PreRead assessment highlights areas of modeled stenosis greater than 30% for vessels 1.8 mm or larger in diameter. This information will be provided as a 2D image of the coronary arteries, with areas of concern color coded by severity. In addition, CT images of each of the three main arteries are provided so physicians can more easily confirm the PreRead color-coded narrowings.

The PreRead assessment is intended to support clinical workflow efficiency, diagnostic accuracy and CT reader consistency as measured by repeatability and reproducibility. In an internal study, the PreRead assessment was 35% more repeatable and 47% more reproducible in classifying percent stenosis than expert CT readers’ (Level 3) classification of the same cases1.

In addition, the HeartFlow Plaque feature is based on a fully automated deep-learning (a form of AI) algorithm for characterizing and quantifying plaque. In an internal study, the HeartFlow Plaque technology was found to be more reliable than expert CT readers in identifying different types of plaque and quantifying total plaque volume.2

About the HeartFlow FFRct Analysis

Starting with a standard coronary CT scan, the HeartFlow Analysis leverages algorithms trained using deep learning and highly trained analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and provides FFRct values along the coronary arteries. This information is used by physicians in evaluating the impact a blockage may be having on blood flow and to determine the optimal course of treatment for each patient. A positive FFRct value (≤0.80) indicates that a coronary blockage is impeding blood flow to the heart muscle to a degree which may warrant invasive management.

Data demonstrating the safety, efficacy and cost-effectiveness of the HeartFlow Analysis have been published in more than 500 peer-reviewed publications, including long-term data out to five years. The HeartFlow Analysis offers the highest diagnostic performance available from a non-invasive test.3 To date, clinicians around the world have used the HeartFlow Analysis for more than 100,000 patients to aid in the diagnosis of heart disease.

About HeartFlow

HeartFlow is the leader in revolutionizing precision heart care, uniquely combining human ingenuity with advanced technology. HeartFlow’s non-invasive HeartFlow FFRct Analysis leverages artificial intelligence to create a personalized three-dimensional model of the heart. Clinicians can use this model to evaluate the impact a blockage has on blood flow and determine the best treatment for patients. HeartFlow’s technology is reflective of our Silicon Valley roots and incorporates over two decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, UK, Canada, Europe and Japan. For more information, visit www.heartflow.com.

Important Information about the Business Combination and Where to Find It

In connection with the proposed Business Combination contemplated by the business combination agreement, dated as of July 15, 2021 (as amended, the “Business Combination Agreement”), by and among Longview Acquisition Corp. II (“Longview”), HF Halo Merger Sub, Inc. and HeartFlow Holding, Inc., the parent company of HeartFlow, Inc., Longview has filed with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 (the “Registration Statement”), which includes a preliminary proxy statement/prospectus and, as amended, will include a definitive proxy statement/prospectus, and certain other related documents, which will be both the proxy statement to be distributed to holders of shares of Longview’s common stock in connection with Longview’s solicitation of proxies for the vote by Longview’s stockholders with respect to the Business Combination and other matters as may be described in the Registration Statement, as well as the prospectus relating to the offer and sale of the securities of Longview to be issued in the Business Combination. Longview’s stockholders and other interested persons are advised to read the preliminary proxy statement/prospectus included in the Registration Statement and the amendments thereto and the definitive proxy statement/prospectus, as well as other documents filed with the SEC in connection with the proposed Business Combination, as these materials will contain important information about the parties to the Business Combination Agreement, Longview and the proposed Business Combination. After the Registration Statement is declared effective, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to stockholders of Longview as of a record date to be established for voting on the proposed Business Combination and other matters as may be described in the Registration Statement. Stockholders will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, and other documents filed with the SEC that will be incorporated by reference therein, without charge, once available, at the SEC’s web site at www.sec.gov, or by directing a request to: Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor, New York, NY 10153, Attention: Mark Horowitz, Chief Financial Officer or to [email protected].

Participants in the Solicitation

Longview and its directors and executive officers may be deemed participants in the solicitation of proxies from Longview’s stockholders with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests in Longview is contained in the Registration Statement for the Business Combination and is available free of charge at the SEC’s web site at www.sec.gov, or by directing a request to Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor, New York, NY 10153, Attention: Mark Horowitz, Chief Financial Officer or to [email protected]. Additional information regarding the interests of such participants is contained in the Registration Statement.

HeartFlow and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Longview in connection with the Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the Business Combination is contained in the Registration Statement.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. HeartFlow’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “indicate,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, HeartFlow’s statements regarding the PreRead assessment, its expected features and capabilities and HeartFlow’s application for FDA clearance of the new product offering. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside Longview’s and HeartFlow’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of Longview and HeartFlow prior to the Business Combination, and the combined company following the Business Combination, to meet the closing conditions in the Business Combination Agreement, including due to failure to obtain approval of the stockholders of Longview and HeartFlow or certain regulatory approvals, or failure to satisfy other conditions to closing in the Business Combination Agreement; (2) the occurrence of any event, change or other circumstances, including the outcome of any legal proceedings that may be instituted against Longview and HeartFlow following the announcement of the Business Combination Agreement and the transactions contemplated therein, that could give rise to the termination of the Business Combination Agreement or could otherwise cause the transactions contemplated therein to fail to close; (3) the inability to obtain or maintain a stock exchange listing of the combined company’s Class A common stock, as applicable, following the Business Combination; (4) the risk that the Business Combination disrupts current plans and operations as a result of the announcement and consummation of the Business Combination; (5) the inability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain its key employees; (6) costs related to the Business Combination; (7) changes in applicable laws or regulations or the healthcare industry; (8) the inability of the combined company to raise financing in the future; (9) the success, cost and timing of HeartFlow’s and the combined company’s product development activities, including market adoption of their current and future products; (10) the inability of HeartFlow or the combined company to obtain and maintain regulatory approval for their current and future products, and any related restrictions and limitations of any approved product; (11) the inability of HeartFlow or the combined company to build effective sales and marketing capabilities to support the combined company’s growth strategy; (12) the inability of HeartFlow or the combined company to maintain HeartFlow’s existing customer, license, and collaboration agreements, and arrangements with commercial and government payers; (13) future changes in clinical guidelines, or the timing of increased adoption and use, if any, of HeartFlow’s products as a result of the publication of positive clinical guidelines that support the use of HeartFlow’s and the combined company’s products; (14) the inability of HeartFlow or the combined company to compete with other companies marketing or engaged in the development of products that aid physicians in the evaluation and treatment of coronary artery disease; (15) the size and growth potential of the markets for HeartFlow’s and the combined company’s products, and each of their ability to serve those markets, either alone or in partnership with others; (16) the pricing of HeartFlow’s and the combined company’s products and reimbursement for medical procedures conducted using HeartFlow’s and the combined company’s products, including future changes to or reductions in reimbursement and payment rates; (17) HeartFlow’s and the combined company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; (18) HeartFlow’s and the combined company’s financial performance; (19) the impact of COVID-19 on HeartFlow’s business and/or the ability of the parties to complete the Business Combination; and (20) other risks and uncertainties indicated from time to time in the proxy statement/prospectus relating to the Business Combination, including those under “Risk Factors” in the Registration Statement, and in Longview’s other filings with the SEC.

The foregoing list of factors is not exclusive. and investors should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Neither HeartFlow nor Longview undertakes or accepts any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based.

No Offer or Solicitation

This communication shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This communication shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended.

Contact

For Investors:
Leigh Salvo or Jack Droogan
Gilmartin Group
[email protected]

For Media:
Jennie Kim
HeartFlow
[email protected]

  1. HeartFlow Internal Study. Results based on Modified CADRADs. December 2021
  2. HeartFlow Internal Study. December 2021
  3. Driessen, R., et al. J Am Coll Cardiol. 2019;73(2),161-73

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LambdaTest launches LambdaTest extension for GitHub Copilot to make test automation pervasive across SDLC and drive developer productivity

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5 hours ago

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May 22, 2024

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NOIDA, India and SAN FRANCISCO, May 22, 2024 /PRNewswire/ — LambdaTest extension for GitHub Copilot enables AI-powered bridge experiences by seamlessly integrating test and dev workflow. It acts as a test automation copilot, assisting developers with quality assurance capabilities across different stages in SDLC, right where they code.

May 22, 2024, Noida/San Francisco: LambdaTest, a leading cloud-based unified testing platform, announced the launch of the LambdaTest extension for GitHub Copilot. This innovative capability revolutionizes the way developers manage and execute test workflows within their integrated development environments (IDEs).
The LambdaTest extension seamlessly integrates with GitHub Copilot Chat bridging the gap between development and testing workflows. Developers can now trigger test execution directly from their GitHub and VS Code environment, eliminating the need to switch between multiple applications. This streamlined process enhances productivity and accelerates software delivery.
With LambdaTest extension, developers can initiate tests effortlessly with a simple command, bringing testing closer to their code. This capability not only saves time but also enhances collaboration among development and testing teams by providing a unified platform for managing quality software releases, faster.
Moreover, real-time feedback integrated into GitHub Copilot empowers developers to iterate more efficiently, at speed, ensuring the quality and stability of their codebase. By conveniently viewing regression run results within their coding environment, developers and testers can quickly identify and address potential issues or bugs, facilitating faster resolution and delivery of high-quality software.
“LambdaTest Extension for GitHub Copilot is a huge milestone in our commitment to enable devs and QA processionals worldwide with frictionless experiences to accelerate software delivery.,” said Mohit Juneja, VP, Strategic Sales and Partnerships, LambdaTest. “Gone are the days of switching between multiple applications; now, developers can design, trigger, and analyze tests with simple prompts in natural language, without switching context from the IDE.”
The benefits of the LambdaTest extension extend beyond just test execution. It also offers powerful analysis tools, allowing developers to dive deep into test data, identify trends, and make data-driven decisions to continuously improve code quality and stability.
LambdaTest remains committed to driving innovation in the field of software testing, and this capability is another testament to that commitment. By providing developers and testers with tools to streamline processes and deliver high-quality software efficiently, LambdaTest continues to support and empower software development teams worldwide.
The LambdaTest extension for GitHub Copilot is now available for developers and testers. To learn more and get started, visit https://github.blog/2024-05-21-introducing-github-copilot-extensions
About LambdaTest LambdaTest is an intelligent and omnichannel enterprise execution environment that helps businesses drastically reduce time to market through Just in Time Test Orchestration (JITTO), ensuring quality releases and accelerated digital transformation. Over 10,000+ enterprise customers and 2+ million users across 130+ countries rely on LambdaTest for their testing needs.
Browser & App Testing Cloud allows users to run both manual and automated tests of web and mobile apps across 3000+ different browsers, real devices, and operating system environments.HyperExecute helps customers run and orchestrate test grids in the cloud for any framework and programming language at blazing-fast speeds to cut down on quality test time, helping developers build software faster.For more information, please visit, https://lambdatest.com
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DeepL announces $300 million investment at $2 billion valuation fueled by global demand for AI language solutions

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7 hours ago

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May 22, 2024

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Index Ventures led heavily oversubscribed round with participation from late-stage investment firms ICONIQ Growth, Teachers’ Venture Growth, and more Rapid enterprise adoption of DeepL has fueled the company’s growth in 60+ global markets for 100,000+ businesses, governments, and other organizationsDeepL’s Language AI Platform for business provides category-leading AI-powered translation and writing solutions COLOGNE, Germany, May 22, 2024 /PRNewswire/ — DeepL, a leading Language AI company, today announced $300 million of investment at a $2 billion valuation. Led by Index Ventures, the heavily oversubscribed round attracted strong support from new investors, who will bring their extensive expertise, connections, and resources to support DeepL’s growth and long-term vision to transform the way companies communicate around the world. Additional late-stage investors, including ICONIQ Growth, Teachers’ Venture Growth, and others, also participated, along with existing investors IVP, Atomico, and WiL.

“We’re approaching an inflection point in the AI boom where businesses who are racing to adopt the technology begin to discern between hype versus solutions that are secure and actually solve real problems in their business,” said Jarek Kutylowski, founder and CEO of DeepL. “This new investment comes during what is on track to be DeepL’s most transformative year yet and is a testament to the crucial role that our Language AI platform has in solving the complex linguistic challenges global companies face today. We’re highly focused on continued growth and innovation to expand our solutions and ensure they remain industry-leading in terms of quality, precision, and security. This will bring us closer to a future where every company, regardless of location, can operate seamlessly on a global scale with our AI.”
The new investment comes during a period of significant growth and momentum for DeepL, which has amassed a customer network of 100,000+ businesses, governments, and other organizations worldwide. This network includes Zendesk, Nikkei, Coursera, and Deutsche Bahn, who rely on its highly accurate and secure enterprise Language AI platform to deliver seamless communication, driving international growth and cost savings. In response to surging demand from global enterprises, DeepL has accelerated its expansion efforts and strategic investments into key markets over the past year. In January 2024, DeepL deepened its commitment to the U.S.—now its third largest market—by opening its first office in the region. The company continues to expand its team in the U.S. to support growing demand.
Within the last 12 months, DeepL has also substantially broadened its product offerings tailored for businesses. In April 2024, the company launched DeepL Write Pro, a writing assistant specifically tailored for business writing, powered by its own proprietary LLM technology. The company also continues to expand the range of languages supported by its platform with the recent additions of Arabic, as well as Korean and Norwegian, bringing its total number of languages to 32.
“DeepL’s runaway success is a bit of an ‘open secret’ in the business community,” said Danny Rimer, who led the investment from Index Ventures. “The company is exceptionally thoughtful about creating cutting-edge AI products that deliver real and immediate value to their customers. Jarek and the rest of the DeepL team are equally research and commercially minded – both of which are key to the company’s success.” Index Ventures is recognized for its investments in highly successful SaaS businesses like Figma, Slack, Wiz, and Scale AI.
Demand for AI solutions among global enterprises is on the rise. A recent IBM study found that 42% are already actively deploying AI and 40% are exploring its potential. Within this rapidly evolving landscape, DeepL is leading the way in applying AI to transform the $67.9 billion language industry, which is projected to grow to $95.3 billion by 2028.
Since its inception in 2017, DeepL has become the Language AI provider of choice for businesses across multiple industries including manufacturing, legal, retail, healthcare, technology, and professional services. The company’s specialized Language AI platform has become a critical investment for global businesses today, addressing a variety of communication challenges ranging from internal communications to customer support and international market expansion. Unlike general-purpose AI systems, DeepL’s cutting-edge translation and writing solutions rely on specialized AI models specifically tuned for language, resulting in more precise translations for a variety of use cases and a reduced risk of hallucinations and misinformation. In business translation and writing, accuracy is paramount, making specialized AI models the most reliable and preferred solution for language challenges.
DeepL’s Language AI platform is also proven to drive significant cost savings and efficiencies. A 2024 Forrester study revealed that the use of DeepL delivered 345% ROI for global companies, reducing translation time by 90% and driving a 50% in workload reduction, underscoring, in our opinion, the power of its platform for businesses looking to grow their revenue and enter new markets faster and at scale.
“At Zendesk we see first hand the power of infusing AI tools into customer experience, and DeepL’s industry-leading translation is a prime example,” said Adrian McDermott, CTO, Zendesk. “The ability to have accurate AI translation allows companies from startups to large enterprises the ability to scale globally, reaching prospects and existing customers in new ways. Zendesk’s open and flexible platform allows for seamless partnerships, and the tangible results we’ve seen so far from joint customers have us looking forward to continued work with DeepL.”
Looking ahead, DeepL will continue to invest in research and product innovation to strengthen its suite of leading AI communication tools for businesses. The company is also doubling down on global market expansion and talent recruitment across multiple areas including AI research, product, engineering, and GTM.
 
About DeepLDeepL is on a mission to break down language barriers for businesses everywhere. Over 100,000 businesses, governments and other organizations and millions of individuals in 63 global markets trust DeepL’s Language AI platform for human-like translation and better writing. Designed with enterprise security in mind, companies around the world leverage DeepL’s AI solutions that are specifically tuned for language to transform business communications, expand markets and improve productivity. Founded in 2017 by CEO Jaroslaw (Jarek) Kutylowski, DeepL today has over 900 passionate employees and is supported by world-renowned investors including Benchmark, IVP and Index Ventures.
Contact:Sebastian RiesOpeners [email protected]+49 1578 058 8488
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Hyundai Motor and Plus Announce Collaboration to Demonstrate First Level 4 Autonomous Fuel Cell Electric Truck in the U.S.

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May 22, 2024

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Hyundai Motor and Plus collaboration aims to enhance road safety and freight efficiencies by demonstrating benefits of XCIENT Fuel Cell truck equipped with Plus’s Level 4 autonomous driving softwareHyundai Motor’s Class 8 XCIENT Fuel Cell truck featuring Plus’s Level 4 SuperDrive™ system is on display at the Plus ACT Expo booth (#2044)LAS VEGAS and SEOUL, South Korea, May 22, 2024 /PRNewswire/ — Hyundai Motor Company (Hyundai Motor) and autonomous driving software leader Plus today unveiled the first Level 4 autonomous Class 8 hydrogen fuel cell electric truck in the U.S. at the Advanced Clean Transportation (ACT) Expo, the largest advanced clean transportation technology and fleet event in North America.

A result of the collaboration between Hyundai Motor and Plus, Hyundai Motor’s XCIENT Fuel Cell truck, equipped with Plus SuperDrive™ Level 4 autonomous driving technology, is on display at the Plus ACT Expo booth (#2044).
The Level 4 autonomous XCIENT Fuel Cell truck is undergoing initial autonomous driving assessments in the U.S., making it the first-ever Level 4 self-driving test on a Class 8 fuel cell electric truck to take place in the country. The collaboration seeks to show that autonomous hydrogen fuel cell trucks can help make trucking safer, more efficient, and more sustainable.
“We are excited to showcase our collaboration with Plus to test Level 4 autonomous driving technology with our Class 8 XCIENT Fuel Cell truck,” said Martin Zeilinger, Executive Vice President and Head of Commercial Vehicle Development at Hyundai. “Hyundai Motor has been driving the energy transition paradigm with our advanced fuel cell technologies. By adding autonomous capabilities to our world’s first mass-produced hydrogen-powered XCIENT Fuel Cell truck, Hyundai is looking forward to providing fleets and vehicle operators additional solutions that enhance road safety and freight efficiencies thanks to Plus’s industry-leading autonomous driving technology.”
First introduced in 2020, Hyundai Motor’s XCIENT Fuel Cell truck has conducted commercial operations in eight countries worldwide, establishing a successful track record of real-world applications and technological reliability.
At last year’s ACT Expo, Hyundai introduced XCIENT Fuel Cell tractor, the commercialized Class 8 6×4 fuel cell electric model, powered by two 90kW hydrogen fuel cell systems and a 350kW e-motor, providing a driving range of over 450 miles per charge even when fully loaded.
Plus’s SuperDrive™ solution is being deployed across the U.S., Europe, and Australia. The system uses a combination of cutting-edge sensors, including LiDAR, radar and cameras, to provide surround perception, planning, prediction and self-driving capabilities.
“We are thrilled to collaborate with Hyundai Motor Company on this important initiative to create more sustainable and safe transportation options. A decarbonized future with autonomous hydrogen fuel cell electric trucks that also improve safety and efficiency is one that Plus is proud to support with our cutting-edge autonomous driving technology,” said Shawn Kerrigan, COO and Co-Founder at Plus.
Hyundai Motor and Plus have released a video highlighting their collaboration, which can be seen here: https://www.youtube.com/watch?v=_d19h_v7abo.  
About Hyundai Motor Company
More information about Hyundai Motor and its products can be found at: https://www.hyundai.com/worldwide/en/ or Newsroom: Media Hub by Hyundai
About Plus
For more information, visit http://www.plus.ai/.
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