Core Insights - ONWARD Medical N.V. has received FDA de novo classification and authorization to market its ARC-EX System, the first FDA-approved technology to improve hand strength and sensation after chronic spinal cord injury (SCI) [1][2] - The ARC-EX System is recognized as a Breakthrough Device and was named one of TIME Magazine's Best Inventions of 2024 [1][7] - The device utilizes non-invasive electrical stimulation to enhance spinal cord function, marking a significant advancement in therapies for individuals with chronic SCI [2][7] Company Overview - ONWARD Medical is focused on developing innovative therapies aimed at restoring movement and independence for individuals with spinal cord injuries and other movement disabilities [8] - The company has a pipeline of technologies, including the investigational ARC-IM System and ARC-BCI System, which incorporates brain-computer interface technology [3][8] - The company is headquartered in the Netherlands and has additional facilities in Switzerland and the United States [9] Clinical Impact - The Up-LIFT clinical study demonstrated that 90% of participants improved in strength or function, and 87% reported enhanced quality of life, with benefits observed up to 34 years post-injury [3][6] - Regaining hand function is prioritized significantly higher than other abilities lost due to paralysis, indicating a strong demand for effective therapies in this area [3] Market Authorization and Future Plans - The current FDA authorization is for clinical use, with home use expected to be authorized by mid-2025 [3] - The company plans to seek CE Mark certification for the ARC-EX System in Europe, with expectations for authorization in the second half of 2025 [3]

Core Viewpoint - Nanox Imaging Ltd has received FDA clearance for its Nanox.ARC system, expanding its imaging capabilities to include pulmonary, intra-abdominal, and paranasal indications, in addition to its previous clearance for musculoskeletal imaging [2][4]. Group 1: FDA Clearance and Technology - The Nanox.ARC is a stationary X-ray system designed for general use, now cleared for multiple imaging indications [2]. - It features a proprietary digital X-ray source and advanced tomosynthesis technology, providing a three-dimensional view of the body and reducing the limitations of traditional 2D X-rays [3][4]. - The system is currently deployed in healthcare facilities across seven states in the U.S., with additional units being shipped worldwide [4]. Group 2: Impact on Healthcare Providers - The FDA clearance allows U.S. healthcare providers to access broader imaging capabilities similar to traditional X-ray devices, enhancing patient care [4]. - The technology aims to reduce patient wait times and improve overall diagnostic efficiency, potentially allowing for faster care without the need for separate imaging facilities [5][6]. - The system is designed for integration into existing clinical workflows, operated by trained professionals in various healthcare settings [5]. Group 3: Company Vision and Future Plans - Nanox aims to drive the transition to preventive healthcare through affordable medical imaging technologies, leveraging AI for smarter diagnostics [7][8]. - The company envisions expanding its technology beyond hospital settings, providing a comprehensive solution from scan to diagnosis [8]. - The Nanox ecosystem includes various components such as Nanox.AI for enhanced imaging analysis and Nanox.CLOUD for data management [9].

Grant supports the first clinical trials studying the potential for brain-computer interface (BCI) and artificial intelligence (AI) technology to restore thought-driven movement after stroke Funding also supports technology development of ARC-BCI System and ARC-IM Lead Approximately 15 million people worldwide experience a stroke each year EINDHOVEN, the Netherlands, Nov. 19, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimula ...

One of the top shareholders of President-elect Donald Trump's media company has unloaded nearly his entire stake, a regulatory filing showed.The Thursday night disclosure to the U.S. Securities and Exchange Commission showed that financial firm ARC Global Investments II and its manager, Patrick Orlando, no longer own more than 5% of Trump Media stock.Orlando, the former CEO of the company that took Trump Media public in a SPAC merger, and ARC, the sponsor of that merger, now hold just 30,147 DJT shares — ab ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

Oil, Gas, Energy, Metals - That's the core of my research.I am a semi-retired former engineer who switched careers in 2018 to focus on capital management. I acquired most of my knowledge about finance and valuation from NYU Professor Damodaran and books like "Margin of Safety" and "The Intelligent Investor."I specialize in fundamental analysis and require both a deep "Margin of Safety" and a "Catalyst" to consider adding a stock to my portfolio. My portfolio usually contains no more than 10 stocks.I joined ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________ Emerging growth company ☐ Form 10-Q _______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-32407 ___________ ...

ARC Reports Financial Results for Third Quarter 2024 —————————————————————— SAN RAMON, CA – (November 4, 2024) – ARC Document Solutions, Inc. (NYSE: ARC), a leading provider of digital printing and document-related services, today reported its financial results for the third quarter ended September 30, 2024. | --- | --- | --- | --- | --- | --- | --- | --- | --- | |----------------------------------------------|-------|-----------------------------------------|-------|----------|-------|--------------------- ...

ARC Document Solutions (ARC) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of $0.06. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -100%. A quarter ago, it was expected that this provider of document services to businesses would post earnings of $0.07 per share when it actually produced earnings of $0.07, delivering no surprise.Over the last four quart ...

Warwick, NY, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Automated Room Controls Inc. (ARC), a subsidiary of Ozop Energy Solutions, Inc. (OZSC), is excited to announce that it will be showcasing its innovative ARC product line at the second annual NYControlled Lighting Controls Event. This event, held on October 29, 2024, at the Metropolitan Pavilion in NYC, is an educational trade show focused on lighting controls, attended by top industry professionals, including designers, contractors, and engineers. Engage with A ...