Latest news with #FDA-required
Yahoo
04-06-2025
- Business
- Yahoo
'Web-Surfing With Your Brain' by 2030? Neuralink's $9B Valuation Sparks Debate Over Musk's Telepathy Timeline
Elon Musk's brain-computer interface company Neuralink has raised $600 million in new funding at a $9 billion valuation, according to Semafor. The fundraising round follows the company's first human implant earlier this year and expands its efforts to develop medical applications for its brain chip technology. Musk has previously stated that humans may be able to surf the web with their thoughts by the end of 2030, Reuters reported. The claim has drawn renewed attention amid the funding news. In January, MIT Technology Review noted that neuroscience experts have questioned the feasibility of this timeline. Don't Miss:Invest where it hurts — and help millions heal:. Neuralink began human trials in 2024 after receiving U.S. Food and Drug Administration approval to implant its brain-computer interface, or BCI, in paralysis patients. The first participant, Noland Arbaugh, underwent surgery in January 2024 and was later shown controlling a computer cursor and playing online chess using only his thoughts, according to Reuters. In May 2024, Neuralink registered a clinical study in the U.S. government trials database, aiming to enroll three participants. The company is also expanding its trial footprint internationally, having received approval from Health Canada in November 2024 to recruit six patients for a study testing the device's safety and efficacy in enabling cursor movement through brain activity. Trending: Maximize saving for your retirement and cut down on taxes: . While early demonstrations suggest meaningful progress, the technology remains highly experimental. Neuralink is currently conducting an early feasibility study called the Precise Robotically Implanted Brain-Computer Interface, with three participants implanted. The company has not yet registered a pivotal trial — the FDA-required phase for commercial approval — and continues to modify its device design, including electrode and surgical robot upgrades, according to MIT Technology Review. Neuralink's valuation has risen sharply to $9 billion, up from an estimated $5 billion in mid-2023, according to Semafor. The publication reported that the recent funding round drew support from existing investors aligned with Elon Musk's other companies, including Tesla Inc. (NASDAQ:TSLA) and SpaceX. Musk has repeatedly positioned Neuralink as a safeguard against artificial intelligence threats. In a May 2 post on X, he stated that Neuralink's brain chips must become widely available to ensure humans remain competitive as AI advances. He previously told CNN in 2023 that brain-computer interfaces could help reduce civilizational risk posed by artificial general global BCI market is projected to reach $6.52 billion by 2030, growing at a compound annual growth rate of 18.15% from 2025 to 2030, according to Grand View Research. Competitors are also gaining traction. Synchron was the first to receive FDA approval to implant a BCI in U.S. patients, and Precision Neuroscience recently announced regulatory clearance for its minimally invasive device. As Neuralink expands its human trials, it faces pressure to keep pace with rivals and regulatory scrutiny. According to Reuters, FDA found quality control issues in the company's animal research lab, and U.S. Department of Agriculture's Inspector General have raised concerns over the pace and integrity of its experiments. With significant competition, regulatory hurdles, and ethical concerns in play, Neuralink's ability to deliver on Musk's ambitious timeline will remain under close watch by investors, scientists, and the public alike. Read Next: Can you guess how many retire with a $5,000,000 nest egg? . Image: Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? TESLA (TSLA): Free Stock Analysis Report This article 'Web-Surfing With Your Brain' by 2030? Neuralink's $9B Valuation Sparks Debate Over Musk's Telepathy Timeline originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
03-06-2025
- Business
- Yahoo
ReposiTrak Adds 50 New Food and Beverage Suppliers to the Queue for the Rapidly Expanding Food Traceability Network
Retailers drive increased focus on food safety and traceability as 50 new suppliers enter the queue to join the ReposiTrak Traceability Network SALT LAKE CITY, June 03, 2025--(BUSINESS WIRE)--ReposiTrak (NYSE:TRAK), the world's largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is proud to add 50 food and beverage suppliers to the queue of companies joining the ReposiTrak Traceability Network® (RTN). These companies will efficiently exchange intricate, FDA-required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) in their supply chains, with the goal of meeting the growing traceability demands of their retail customers. Among the 50 new suppliers are many whose customers require traceability for all foods, not only Food Traceability List foods. One is a company known for providing nuts, confections, and nostalgic snacks for more than 80 years. Another, founded more than 150 years ago, has deep roots in the snack food sector with their iconic cookies and crackers. A third began in the early 1970s and has grown into a global leader in specialty coffee, offering a wide range of premium beverages, packaged drinks and coffee products available in retail stores worldwide. "Suppliers large and small can use ReposiTrak to share traceability data with their retail customers in the exact format those customers require," stated Randy Fields, chairman and CEO of ReposiTrak. "We run every traceability data file through a 500+ point error detection process, to ensure it meets both FDA regulations and the often-stricter requirements of retail partners, removing complexity and reducing the risk of noncompliance." The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee. About ReposiTrak ReposiTrak (NYSE: TRAK) provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak's integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit View source version on Contacts Investor Relations Contact:John Merrill, CFOInvestor-relations@ OrFNK IRRob Fink646.809.4048rob@
Business Wire
03-06-2025
- Business
- Business Wire
ReposiTrak Adds 50 New Food and Beverage Suppliers to the Queue for the Rapidly Expanding Food Traceability Network
SALT LAKE CITY--(BUSINESS WIRE)--ReposiTrak (NYSE:TRAK), the world's largest food traceability and regulatory compliance network, leveraging its established inventory management and out-of-stock reduction SaaS platform, is proud to add 50 food and beverage suppliers to the queue of companies joining the ReposiTrak Traceability Network® (RTN). These companies will efficiently exchange intricate, FDA-required Key Data Elements (KDEs) for each Critical Tracking Event (CTE) in their supply chains, with the goal of meeting the growing traceability demands of their retail customers. Among the 50 new suppliers are many whose customers require traceability for all foods, not only Food Traceability List foods. One is a company known for providing nuts, confections, and nostalgic snacks for more than 80 years. Another, founded more than 150 years ago, has deep roots in the snack food sector with their iconic cookies and crackers. A third began in the early 1970s and has grown into a global leader in specialty coffee, offering a wide range of premium beverages, packaged drinks and coffee products available in retail stores worldwide. 'Suppliers large and small can use ReposiTrak to share traceability data with their retail customers in the exact format those customers require,' stated Randy Fields, chairman and CEO of ReposiTrak. 'We run every traceability data file through a 500+ point error detection process, to ensure it meets both FDA regulations and the often-stricter requirements of retail partners, removing complexity and reducing the risk of noncompliance.' The ReposiTrak Traceability Network requires no additional hardware or software and the ReposiTrak team assists in making the connections needed under the new regulation. Suppliers can connect to an unlimited number of trading partners and share data for a low, flat fee. About ReposiTrak ReposiTrak (NYSE: TRAK) provides retailers, suppliers, food manufacturers and wholesalers with a robust solution suite to help reduce risk and remain in compliance with regulatory requirements, enhance operational controls and increase sales with unrivaled brand protection. Consisting of three product families – food traceability, compliance and risk management and supply chain solutions – ReposiTrak's integrated, cloud-based applications are supported by an unparalleled team of experts. For more information, please visit
Yahoo
28-05-2025
- Business
- Yahoo
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
New digital-first solution enables patient engagement and retention while maintaining scientific rigor throughout 15-year CGT trials PALO ALTO, Calif., May 28, 2025--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. "Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors," said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. "With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor." Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Learn more about Medable's new digital-based LTFU model at American Society of Clinical Oncology's (ASCO) 2025 Annual Meeting (May 30-June 3) in Chicago at Medable Booth #10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024. View source version on Contacts Media Contact: Lisa Barbadora, Barbadora INK for Medable+1 (610) 420-3413lbarbadora@ / media@
Business Wire
28-05-2025
- Health
- Business Wire
Medable Introduces Long-Term Follow-Up Model for Cell & Gene Therapy (CGT) Trials to Reduce Costs and Improve Patient Access
PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Inc., a leading technology platform provider for decentralized clinical trials, today unveiled its digital-first Long-Term Follow-Up (LTFU) model for cell and gene therapy (CGT) trials. Medable's platform reduces the burden on patients and sites involved in complex CGT trials and enhances scientific integrity with sustainable data capture across the FDA-required 15-year follow-up period for certain CGTs, including those using genome-editing techniques like CRISPR-Cas9. This extended monitoring period is essential for tracking delayed adverse events, understanding the durability of the therapy, and ensuring the long-term impact on patients – but can add significant hardships. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution. Share CGTs offer transformative potential yet they also require prolonged safety monitoring, often spanning 15 years post-treatment. Traditional models for LTFU impose logistical and financial challenges on participants, contributing to lower participation and high attrition rates over time. According to a 2024 survey conducted by the Emily Whitehead Foundation and Catalyst Healthcare Consulting, 20% of CAR T-cell therapy patients stop participating in long-term follow-up altogether, with 80% of that group ceasing participation at or after five years post-treatment. Distance to sites, lack of awareness about local follow-up options, and burdensome travel are frequently cited as key barriers. 'Long-term follow-up is essential to ensure the durability and safety of advanced therapies, but the current system isn't working for patients or sponsors,' said Dr. Pamela Tenaerts, Chief Medical Officer at Medable. 'With our new LTFU model, we're reimagining how post-treatment data is captured - putting patients at the center while ensuring scientific and regulatory rigor.' Medable's digital-first LTFU offering includes: Remote and Hybrid Patient Interaction: Patients can engage in follow-up through flexible virtual, in-person, or blended formats that meet their individual needs and life circumstances. Seamless Transition from Parent Trials: Integrated workflows and data continuity ensure a frictionless handoff from interventional studies to long-term observational follow-up. Patient-First Data Capture and Adherence Monitoring: Leveraging mobile technology, patient reported questionnaires and local healthcare providers to track key endpoints and ensure consistent participation over time. Personalized Patient Communication: Ongoing engagement through tailored content, reminders, and support tools to build trust and maintain long-term connection. By embracing a digital, patient-centric approach, Medable's model addresses key gaps in traditional LTFU execution – improving retention, increasing diversity, and reducing the long-term cost burden for both sponsors and sites. Medable Booth # 10105. About Medable Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable's platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.
