Latest news with #Device
Business Wire
24-06-2025
- Business
- Business Wire
Heather Wilberger Joins NSF as Vice President and Chief Information and Digital Officer
ANN ARBOR, Mich.--(BUSINESS WIRE)-- NSF, a leading global public health and safety organization, has named Heather Wilberger its Vice President and Chief Information and Digital Officer. In this role, Wilberger will lead the execution of NSF's technology roadmap, supporting the digitization of core processes, optimizing the organization's IT application footprint and infrastructure, and leveraging AI and data analytics to deliver innovative solutions to clients and team members worldwide. 'Heather's proven track record of upgrading enterprise-wide technology stacks and leveraging data to drive performance makes her a strong fit for NSF,' said Pedro Sancha, President and CEO of NSF. 'Her people and business-oriented leadership experience will help us accelerate NSF's growth and scale our global impact through connected, cutting-edge technology, furthering our mission to improve human and planet health.' Wilberger has more than two decades of executive leadership in technology, business transformation, and innovation within diverse organizations. She previously served as Chief Transformation and Information Officer at Vince, where she led the charge in driving a strategic vision to blend operational and tactical excellence. Prior to Vince, she managed IT teams at Detroit-based real estate companies Bedrock and Rocket Mortgage. 'It's an honor to join the NSF team fresh off their success of a landmark year of delivering unprecedented value to clients and celebrating their 80 th anniversary,' said Wilberger. 'I'm eager to elevate the work of ensuring our technology and digital operations are airtight, so we can move efficiently and surefootedly in service of our mission.' Wilberger holds a Bachelor of Science in Business Administration from Southern Oregon University. For more information on NSF, visit About NSF NSF is an independent, global services organization dedicated to improving human and planet health for more than 80 years by developing public health standards and providing world-class testing, inspection, certification, advisory services and digital solutions to the food, nutrition, water, life sciences and consumer goods industries. NSF has 40,000 clients across all continents and is a World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Medical Device Safety.
Yahoo
10-06-2025
- Health
- Yahoo
PA bills will expand access to opioid overdose reversal agents
PENNSYLVANIA (WTAJ) — Two bills will soon be introduced to help provide more resources to first responders and law enforcement to fight opioid overdoses. Representatives Chris Pielli and Brian Munroe, in a memo to lawmakers, wrote that the current practice in Pennsylvania is 'outdated.' Noting that the Department of Health only allows the use of naloxone despite other options being available. The CDC reported that deaths involving opioids were estimated to be over 54,000. However, from December 2023 to December 2024, drug overdose deaths in Pennsylvania dropped by 29.94%. Two states, Nevada and South Dakota, were the only ones with increases. Both saw increases of over 4%. Pennsylvania lawmakers advance bill expanding no-cost breast cancer diagnostics Naloxone is used by law enforcement and other first responders to reverse the effects of an opioid overdose. Naloxone works by attaching itself to opioid receptors and then reversing and blocking the effects of opioids. In the CDC's most recent report, they also listed synthetic opioids, like fentanyl, as being the cause of the largest number of overdose deaths. Fentanyl is 50 times stronger than heroin and 100 times stronger than morphine, according to the representatives. They argue that fentanyl is so strong that it can outlast the effects of naloxone and cause people to 're-overdose.' That's why they feel that first responders should have access to things like nalmefene, which is a longer-lasting opioid antagonist. Currently, nalmefene is only available by prescription. 'While naloxone is a crucial tool for first responders and law enforcement, it cannot be our only option,' The representatives said. The two bills that they will be introducing would do the following: Amend the Controlled Substance Drug, Device, and Cosmetic Act to allow nalmefene as an approved opioid antagonist for use over the counter. Direct the Pennsylvania Department of Health to change their current standing order to include nalmefene as an approved opioid reversal agent for over the counter use. 'We cannot continue to discount the ability of other opioid antagonists to save lives. While our policy continues to stagnate, the illicit drug market evolves, adapts, and finds new ways to draw Pennsylvanians into the throes of addiction or, in an unfortunate number of cases, death,' the representatives added. If you or someone you know is struggling with substance abuse, you can contact the Substance Abuse and Mental Health Services Administration's free, confidential, 24/7, 365-day-a-year treatment referral and information service at 1-800-662-HELP (4357). Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Business Standard
10-06-2025
- Business
- Business Standard
OneSource Specialty jumps as Bangalore facility passes USFDA check
OneSource Specialty Pharma rose 3.98% to Rs 2,006 after the company announced that its flagship drug-device combination facility in Bangalore has retained its compliance status with the U.S. Food and Drug Administration (USFDA). The facility received a "Voluntary Action Indicated" (VAI) classification from the USFDA, following an inspection conducted between March 20 and March 28, 2025. During the inspection, the agency issued a Form 483 with four observations. However, after reviewing the company's comprehensive response and commitments, the agency has officially closed the inspection. Neeraj Sharma, managing director & CEO, said "The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase." OneSource Specialty Pharma is a pure-play specialty pharmaceutical CDMO. The company focuses on the development and manufacturing of complex pharmaceutical products including biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatine capsules). It has five manufacturing facilities approved by global regulatory authorities and a dedicated team of over 1,200 professionals. On a consolidated basis, OneSource Specialty Pharma reported net profit of Rs 98.50 crore in Q4 March 2025 as against net loss of Rs 40.17 crore in Q4 March 2024. Net sales surged 482.38% YoY to Rs 425.95 crore in Q4 March 2025.
Yahoo
05-06-2025
- Business
- Yahoo
HeartSciences recesives FDA BDD for Aortic Stenosis ECG algorithm
HeartSciences (HSCS) announced that the U.S. Food and Drug Administration has granted Breakthrough Device designationless than BDD, for its Aortic Stenosis ECG algorithm. The algorithm would offer a novel, AI-driven ECG solution capable of detecting moderate-to-severe aortic stenosis. Once cleared by the FDA, the algorithm will be accessible through HeartSciences' MyoVista Insights cloud-based platform which would directly integrate with hospital electronic health record systems, requiring no additional hardware or testing. This technology provides several key clinical advantages: Detection in asymptomatic or under-evaluated patients who may not yet show signs of AS; Real-time or retrospective analysis using existing ECG data already captured during routine care; Expanded access to early diagnosis, especially in underserved areas lacking specialized cardiac imaging or providers. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on HSCS: Disclaimer & DisclosureReport an Issue Heart Test Laboratories Files Certificate for Preferred Stock Heart Test Laboratories Secures Foundational Patent for AI-ECG HeartSciences announces grant by USPTO for ECG assessment of heart function HeartSciences signs first MyoVista Insights platform customer Heart Test Laboratories Announces $15M Securities Offering Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Verge
30-05-2025
- Health
- The Verge
That's what researchers at the University of Texas at Austin are proposing in
Track your mental stress... with a forehead e-tattoo? this paper published in Device. In an interview with IEEE Spectrum, co-author Nanshu Lu says it's meant to help people in 'high-stakes, high-demand' jobs monitor their stress in real-time. The e-tattoo measures brainwaves and eye movements to decode mental workloads to help prevent people in stressful jobs from reaching a breaking point. Obviously, this is research and not an actual thing yet — but it sure does look cyberpunk.
