Roivios Initiates Landmark Study to Demonstrate Safety and Efficacy of an Innovative Renal Assist Device for Cardiac Surgery Patients With Kidney Disease NASSAU, Bahamas , Dec. 19, 2024 /PRNewswire/ -- Roivios , a pioneering clinical-stage medical device company dedicated to revolutionizing kidney health, proudly announces that its research and development arm, 3ive Labs, has secured approval for an Investigational Device Exemption (IDE) from the FDA. This approval paves the way for a pivotal trial of the JuxtaFlow Renal Assist Device (RAD), marking a transformative step forward in enhancing outcomes for cardiac surgery patients with renal insufficiency. The GRADIENT ( G roundbreaking R enal A ssist D evice I ntervening to EN hance cardio T horacic surgery outcomes) trial is designed to address the critical need for renal support among cardiac surgery patients undergoing cardiopulmonary bypass (CPB). These patients often face increased risks of postoperative complications, such as worsening renal dysfunction, which can lead to extended ICU stays and increased mortality. "The GRADIENT Trial offers an invaluable opportunity to further explore renal support during cardiac surgery," said Dr. Evelio Rodriguez , a renowned heart surgeon at Ascension Saint Thomas in Nashville, TN , and the National Principal Investigator of the GRADIENT trial. "The JuxtaFlow device offers new hope for some of our most vulnerable patients." JuxtaFlow RAD is an innovative device designed to potentially improve kidney function during times of acute stress. By applying a gentle suction to the kidney's outlet, it aims to enhance blood filtration more efficiently. This groundbreaking approach was recognized with an FDA Breakthrough Device Designation in April. The GRADIENT study will be a prospective, multicenter, randomized, controlled, open-label trial that plans to enroll patients with renal insufficiency (eGFR 15-60 ml/min) undergoing elective or urgent cardiac surgery requiring CPB. The study seeks to evaluate the safety and effectiveness of the JuxtaFlow RAD to sustain or enhance renal function during and following CPB surgery. "Achieving Breakthrough Device Designation was instrumental in securing IDE approval," noted John Erbey , Chief Executive Officer at Roivios. "This initiative is the culmination of a decade of technological and clinical advancements in addressing kidney disease management challenges. Our ongoing dialogue with the FDA is paving the way for more effective management, empowering patients to thrive. We are eager to commence IDE enrollment and explore the JuxtaFlow RAD's potential to improve surgical outcomes and enhance patient quality of life." For more information about Roivios and the JuxtaFlow Renal Assist Device, please visit Roivios.com . About JuxtaFlow RAD The JuxtaFlow RAD is a pioneering investigational device set to transform kidney support therapy. Acknowledging the harmful effects of fluid accumulation and pressure on the kidneys, Roivios has advanced beyond traditional blood filtration methods that can further stress the kidneys. By applying mild, controlled negative pressure within the kidney's collecting system, the device has the potential to maintain and improve filtration and support recovery. This novel approach holds promise for a compelling value proposition by preserving kidney function and expediting patient recovery, ultimately reducing hospital stays and associated costs. Equipped with a proprietary specialized catheters and pump, the device optimizes kidney function during critical recovery periods, such as post-surgery. Currently, the JuxtaFlow RAD is under investigation and is not available for sale in any geography. About Roivios Roivios is a clinical-stage medical device company committed to pioneering solutions for kidney health. Our lead product, the JuxtaFlow Renal Assist Device (RAD), is designed to preserve kidney function and offer a proactive approach to managing kidney disease. We aim to demonstrate improved renal outcomes, potentially reducing the need for dialysis, and lowering healthcare costs. Holding proprietary patents in key kidney technologies, we aim to revolutionize kidney disease management. With plans to extend its application beyond kidney disease to various medical settings, Roivios is preparing for a transformative U.S. launch, aiming to redefine kidney disease management and improve patient quality of life. Discover more at roivios.com . This release contains forward-looking statements subject to risks and uncertainties. Actual results may differ significantly. Media Contact : Kelly Krueger , Krueger PR, kelly@kruegerpr.com View original content to download multimedia: https://www.prnewswire.com/news-releases/fda-grants-ide-approval-for-the-pivotal-trial-of-the-juxtaflow-renal-assist-device-rad-302336698.html SOURCE Roivios, ltdBy Tom Hals (Reuters) -A license dispute between Arm Holdings and Qualcomm went before a jury on Thursday after attorneys from both sides completed closing arguments. The jury in a U.S. federal court in Delaware is considering whether Qualcomm or Nuvia, a startup Qualcomm purchased for $1.4 billion in 2021, breached a license agreement with U.K.-based Arm, which supplies intellectual property to both firms. The case could upend Qualcomm’s push into the PC market with a chip meant to rival Apple and Intel on speed. During closing arguments, Qualcomm’s legal team urged the eight-member jury to find the chipmaker had not breached a contract with Arm, warning that the British chip designer was using its lawsuit to try to gain leverage over makers of smart phone chips. Qualcomm lawyer Karen Dunn told jurors that Arm is hoping to force Qualcomm to destroy its recently launched high-speed chips for AI laptops and then threaten similar license partners who build mobile phone chips off its technology. “You can bet the world is watching here,” Dunn said to the jurors in her closing argument. Arm’s lawyer Daralyn Durie warned the jury such allegations were distractions from the issue they must decide: whether Qualcomm and Nuvia, the start-up it acquired in 2021, breached license agreements. “It’s an effort to get you to think about things that have nothing to do with the breach of the contract,” Durie said. In 2022, Arm said Nuvia and Qualcomm had breached Arm’s contract for Nuvia technology and in response the British company terminated the agreement, which obligated Nuvia to destroy the tech built based on that technology. Qualcomm argues that the Nuvia chip designs in question were created independently from Arm. Arm’s attorney Durie said if Qualcomm didn’t want to be forced to destroy its microprocessors it should have complied with the terms of its license. “The decision to go ahead and use all this stuff without a license, that was their choice,” Durie said. “Now they are saying that was a bad decision and they are unhappy. But that was their decision not ours.” The jury met for three and a half hours without reaching a verdict and will resume deliberations on Friday morning. In the trial that started on Monday, Arm sought to portray Qualcomm’s moves as a first-of-its-kind flouting of standard contractual terms the British company had used successfully for decades and that would have upended its business model. At stake for Qualcomm was annual savings of up to $1.4 billion by using the Nuvia designs while claiming the work was done at Qualcomm, which would carry a less expensive licensing deal, Arm attorneys said. Qualcomm claimed Arm misled it into disbanding its own design team, increasing its dependence on Arm technology and then trying to raise royalty rates as much as 400%. It also pointed to internal Arm documents that it said showed Arm was plotting to get into the chip making business while undermining Qualcomm. Arm’s Chief Executive Rene Haas dismissed those allegations. (Reporting by Tom Hals in Delaware and Stephen Nellis in San Francisco; Writing by Max A. Cherney; Editing by Saad Sayeed and Sonali Paul) Disclaimer: This report is auto generated from the Reuters news service. ThePrint holds no responsibility for its content. var ytflag = 0;var myListener = function() {document.removeEventListener('mousemove', myListener, false);lazyloadmyframes();};document.addEventListener('mousemove', myListener, false);window.addEventListener('scroll', function() {if (ytflag == 0) {lazyloadmyframes();ytflag = 1;}});function lazyloadmyframes() {var ytv = document.getElementsByClassName("klazyiframe");for (var i = 0; i < ytv.length; i++) {ytv[i].src = ytv[i].getAttribute('data-src');}} Save my name, email, and website in this browser for the next time I comment. Δ document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() );
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No. 2 UConn falls again in Maui, losing 73-72 to Colorado on Jakimovski's off-balance layupNate Johnson scores 25 as Akron defeats Alabama State 97-78TAMPA, Fla. , Nov. 26, 2024 /PRNewswire/ -- Partsol is proud to announce a significant agreement with the United States Army for a technology-enabled service subscription powered by our proprietary Cognitive AI and Absolute Truth algorithms. This partnership represents a pivotal step in advancing precision, efficiency, and actionable insights for mission-critical operations. Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
NoneWASHINGTON (AP) — Former Rep. Matt Gaetz said Friday that he will not be returning to Congress after withdrawing his name from consideration to be attorney general under President-elect Donald Trump amid growing allegations of sexual misconduct. “I’m still going to be in the fight, but it’s going to be from a new perch. I do not intend to join the 119th Congress,” Gaetz told conservative commentator Charlie Kirk, adding that he has “some other goals in life that I’m eager to pursue with my wife and my family.” The announcement comes a day after Gaetz, a Florida Republican, stepped aside from the Cabinet nomination process amid growing fallout from federal and House Ethics investigations that cast doubt on his ability to be confirmed as the nation’s chief federal law enforcement officer. The 42-year-old has vehemently denied the allegations against him. Gaetz’s nomination as attorney general had stunned many career lawyers inside the Justice Department, but reflected Trump’s desire to place a loyalist in a department he has marked for retribution following the criminal cases against him. RELATED COVERAGE Gaetz’s withdrawal highlights how incoming presidents often lose Cabinet nominees Trump convinced Republicans to overlook his misconduct. But can he do the same for his nominees? Republicans rally around Hegseth, Trump’s Pentagon pick, as Gaetz withdraws for attorney general Hours after Gaetz withdrew, Trump nominated Pam Bondi, the former Florida attorney general, who would come to the job with years of legal work under her belt and that other trait Trump prizes above all: loyalty. What to know about Trump’s second term: Staffing the administration: Here are the people Trump has picked for key positions so far. Plus, a look at recess appointments and how could Trump use them to fill his Cabinet. Follow all of our coverage as Donald Trump assembles his second administration. It’s unclear what’s next for Gaetz, who is no longer a member of the House. He surprised colleagues by resigning from Congress the same day that Trump nominated him for attorney general. Some speculated he could still be sworn into office for another two-year term on Jan. 3, given that he had just won reelection earlier this month. AP AUDIO: Matt Gaetz says he won’t return to Congress next year after withdrawing name for attorney general AP Washington correspondent Sagar Meghani reports Matt Gaetz says he is done with Congress. But Gaetz, who has been in state and national politics for 14 years, said he’s done with Congress. “I think that eight years is probably enough time in the United States Congress,” he said.
Percentages: FG .409, FT .533. 3-Point Goals: 16-33, .485 (Mack 6-9, Hines 3-5, Knox 2-4, Walker 2-4, Bass 2-7, Madlock 1-3, Simpsom 0-1). Team Rebounds: 7. Team Turnovers: None. Blocked Shots: 2 (Andrews, Walker). Turnovers: 10 (Hines 3, Simpsom 3, Okon 2, Bass, Kaego). Steals: 6 (Andrews, Hines, Knox, Mack, Madlock, Simpsom). Technical Fouls: Kaego, 00:50 first. Percentages: FG .464, FT .783. 3-Point Goals: 15-35, .429 (Hardman 6-7, N.Johnson 3-5, Scott 2-5, T.Johnson 2-6, Gray 1-1, Harris 1-5, Lyles 0-2, Young 0-4). Team Rebounds: 4. Team Turnovers: 2. Blocked Shots: 1 (Musiime-Kamali). Turnovers: 9 (N.Johnson 2, Okonkwo 2, Scott 2, Young 2, Musiime-Kamali). Steals: 6 (Young 2, Gray, N.Johnson, Okonkwo, Scott). Technical Fouls: Young, 00:50 first. A_1,589 (5,500).FDA Grants IDE Approval for the Pivotal Trial of the JuxtaFlow® Renal Assist Device (RAD)'Weak leadership': Garin blames Duterte-era DOH chief for 7M expired Covid-19 jabs