Latest news with #CE-marked
Yahoo
7 days ago
- Business
- Yahoo
Subtle Medical Expands in Latin America: SubtleHD™ Now Commercially Available in Chile, Distributed by Hospiline
MENLO PARK, Calif., May 29, 2025 /PRNewswire/ -- Subtle Medical, a global leader in AI-powered medical imaging software, announced today the commercial availability of SubtleHD™ in Chile, marking an important step in expanding access to advanced imaging solutions across Latin America. The company also confirmed it will partner with Hospiline, a trusted regional distributor that currently supports Subtle Medical's growth in Brazil. SubtleHD™ is an FDA-cleared and CE-marked deep learning technology that transforms the quality of MRI images and enables up to 80% time savings on some sequences. It integrates seamlessly into existing clinical workflows, extending the life and performance of existing MRI scanners, an especially critical need across Latin America, where aging imaging infrastructure is common. In Brazil, for example, over 66% of MRI scanners are more than six years old, while demand for MRI exams is growing rapidly, estimated at 30,000 scans per million inhabitants per year. As patient volumes rise, public institutions often face long wait times, and many providers are challenged to meet demand with outdated equipment. SubtleHD helps imaging providers unlock new scan slots without purchasing new hardware, improving operational efficiency and patient throughput. With SubtleHD, healthcare institutions in Chile can now benefit from: Improved image quality even on older MRI systems Faster exam times, helping reduce patient backlog Vendor-neutral compatibility with existing infrastructure "We're thrilled to expand access to SubtleHD in Chile," said Josh Gurewitz, Chief Commercial Officer, at Subtle Medical. "With the support of Hospiline, imaging providers across the region can now harness AI to overcome infrastructure gaps, boost productivity, and elevate diagnostic confidence." About Subtle Medical Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical's solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care. Learn more and request a demo at About Hospiline Hospiline is a trusted distributor of advanced medical technologies across Latin America, committed to delivering innovative solutions that elevate patient care and clinical performance. United by a vision of excellence, we partner with leading global healthcare innovators to bring the most modern, effective technologies to hospitals, clinics, and imaging centers throughout the region. Our mission is to support and optimize the healthcare ecosystem by ensuring access to cutting-edge medical products that enhance outcomes and drive operational efficiency. Media ContactAnna Menyhart-BorroniHead of Marketinganna@ Source: BrazilUMass Medical School eScholarship SOURCE Subtle Medical, Inc. Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Int'l Business Times
28-05-2025
- Business
- Int'l Business Times
Beyond Safety and Efficacy: Medical Brands Redefines Medical Self-Care Through a Human Lens
At the center of Medical Brands is the belief that effective self-care products are the most powerful when they don't burden the mind and body. For over a decade, the company has been dedicated to pioneering a new way of thinking, one rooted in convenience, innovation, and people-centrism. Continuously committed to addressing the ever-changing customer needs, Medical Brands develops, patents, trademarks, manufactures, and delivers product concepts, each one supported by substantiated clinical data. Whether through their own brands or co-creating with established medical self-care names, Medical Brands' goal is to stand at the cutting edge of self-care innovation. Its products combine years of expertise, extensive R&D, regulatory requirements, and a dedication to addressing users' needs. Therefore, they fill the gap between brand owners and product development, making innovative self-care accessible to all. Wart Removal Pen Applicator by Medical Brands Leveraging the favorable European regulations allowing CE-marked products for distribution across all EU countries and countries with mutual recognition, Medical Brands has grown rapidly, today offering B2B and B2C contracts across the globe. This fusion of regulatory understanding, speed-to-market acumen, and human-driven innovation is shaped by the people who built Medical Brands. CEO and President Maikel Hendriks brings a wealth of engineering experience to the table. Today, he harnesses that knowledge to design and develop convenient applicators and innovative products. "In traditional pharma, you think immunologically, pharmacologically, and metabolically," he says. "But in engineering, you think physically. That's what makes Medical Brands so unique." With more than 30 finished products, over 20 in the pipeline, and multiple tried and tested patents , the power of this combination is evident. Hendriks credits Medical Brands' team of 28 professionals, from engineers and designers to pharmacists and supply chain specialists, as the engine that made this success possible. With this diverse expertise, the company produces in-house with its own machinery, making production faster and more scalable. From 3D printers to active medical ingredients, it ensures full control over the final product's quality. Results? A comprehensive suite of products that treat people as users, not patients. That mindset blends safety, efficacy, reliability, and convenience, working in harmony with the body's natural processes to enhance well-being. Hendriks illustrates that by offering product examples, for instance, a precise wart pen applicator that makes treatment a breeze. Elephant-Shaped Bottle by Medical Brands With a complex formula locked in simple packaging, Medical Brands reimagines self-care devices by creating more than an effective treatment; it creates a unique experience. But it's also about appeal. For instance, its cough spray for kids in an elephant-shaped bottle makes the application feel more fun and lighthearted. On the other hand, its nail fungus treatment comes with an added benefit: a colored nail polish that attacks the problem while making the user happy. The company also creates innovation by combining medical monographs with convenient applicators, making otherwise inaccessible treatment within reach for all. At its core, Medical Brands believes that with the right self-care, users can minimize the risks of illness and doctor visits. "Today, you can care for your body at home," adds Hendriks. "We're not reinventing the wheel; we're just making this process more comfortable for users' benefit." Looking ahead, Medical Brands is planning to grow its line to wound treatment alternatives, blending the power of substance-based medical devices and electronics. Additionally, with talks of geographical expansion underway, it remains excited about redefining self-care medical devices in Europe and beyond. "When you're driving self-care to new levels, innovation comes first," Hendriks concludes. "Conventions limit possibilities, and that stifles progress. That's why our mission is to contribute to the healthcare system by empowering people to treat themselves. That's the perfect balance between breaking the rules without breaking regulations, which is what Medical Brands is all about."
Yahoo
24-05-2025
- Business
- Yahoo
RVTY Stock Falls Despite the Latest Launch of Automated Instrument
Revvity, Inc. RVTY announced the launch of its new IDS i20 analytical random-access platform from EUROIMMUN. Per management, it is expected to enable full automation of chemiluminescence immunoassays (ChLIA). The IDS i20 instrument is equipped with the ability to process up to 140 tests per hour (assay dependent) and is the latest addition to RVTY's well-established IDS i-device series. The latest product availability is expected to boost Revvity's Immunodiagnostics product line under the broader Diagnostics segment. Following the announcement, shares of the company lost nearly 2.9% till yesterday's closing. Historically, the company has gained a top-line boost from its various product launches. Although the latest product availability is likely to be beneficial for RVTY's top-line growth going forward, the stock declined overall. Revvity currently has a market capitalization of $10.67 billion. It has an earnings yield of 5.3%, favorable than the industry's 4.1%. In the last reported quarter, RVTY delivered an earnings surprise of 5.2%. Per Revvity, the IDS i20 platform is a CE-marked and FDA-listed device that will likely allow laboratories to consolidate multiple specialty tests on a unique single instrument with greater reagent capacity and higher test throughput compared to existing offerings. The IDS i20 platform is expected to offer fully automated processing of specialty assays in endocrinology, allergy, autoimmune and infectious diseases, Alzheimer's disease and therapeutic drug monitoring. Management believes that the IDS i20 instrument will be able to support Revvity's customers in transitioning from manual and semi-automated processing to a fully automated solution for enhanced immunodiagnostics workflows. Per a report by Grand View Research, the global ChLIA market was estimated at $11.71 billion in 2023 and is anticipated to witness a CAGR of 4.6% between 2024 and 2030. Factors like the growing emphasis on early disease detection and increased efforts by pharmaceutical companies in drug discovery and development are likely to drive the market. Given the market potential, the latest product launch is expected to be a significant milestone for Revvity and boost its business. Last month, Revvity announced its first-quarter 2025 results, wherein its Diagnostics segment recorded a robust year-over-year revenue growth both on a reported and organic basis. In March, Revvity announced the launch of EUROIMMUN's CE-marked Anti-Measles Virus ELISA 2.0 (IgG) to support the diagnosis of a measles virus infection or to determine the immune status against measles virus. In January, Revvity received the FDA's 510(k) clearance for EUROIMMUN's automated chemiluminescence-based immunoassay test for free testosterone. Shares of the company have lost 20.2% in the past year compared with the industry's 20.9% decline. The S&P 500 has gained 10% in the same time frame. Image Source: Zacks Investment Research Currently, RVTY carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Hims & Hers Health, Inc. HIMS, Cencora, Inc. COR and Integer Holdings Corporation ITGR. Hims & Hers, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 36.5%. HIMS' earnings surpassed estimates in two of the trailing four quarters, missed once and broke even in the other, the average surprise being 19.6%. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Hims & Hers' shares have surged 217.1% compared with the industry's 13.5% growth in the past year. Cencora, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.8%. COR's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 6%. Cencora has rallied 32.5% against the industry's 20.9% decline in the past year. Integer Holdings, sporting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 18.4%. ITGR's earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 2.8%. Integer Holdings' shares have lost 3.7% compared with the industry's 14.7% plunge in the past year. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Cencora, Inc. (COR) : Free Stock Analysis Report Integer Holdings Corporation (ITGR) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report Revvity Inc. (RVTY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Miami Herald
21-05-2025
- Business
- Miami Herald
CORRECTING and REPLACING: Tribun Health Achieves FDA Clearance for CaloPix Digital Pathology Platform With Dual Scanner Compatibility
[CORRECTED RELEASE] Updated to clarify reference to dual-scanner FDA clearance. PARIS, FRANCE / ACCESS Newswire / May 21, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management system, CaloPix®, has received FDA 510(k) clearance for use with two leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360MD and the Leica Aperio GT450 DX. This double clearance is representing a major step forward for the U.S. adoption of vendor-agnostic, enterprise-grade solutions. This clearance builds on CaloPix's strong regulatory track record: the solution is CE-marked, Health Canada-approved, and trusted by more than 100 hospitals and laboratories across Europe and Canada. With over 1,000 active users of CaloPix® worldwide, this milestone underscores the platform's scalability, performance, and rapid adoption across diverse healthcare systems. Now, with FDA clearance secured, Tribun Health is ready to bring its proven enterprise solution to hospitals and labs across the United States. Besides these regulatory achievements, CaloPix® has also been recognized three times as "Best in KLAS" for digital pathology, a global benchmark for excellence in healthcare IT. This prestigious recognition highlights Tribun Health's commitment to customer satisfaction, operational excellence, and product innovation. "This is a major commercial and clinical milestone for us," said Jean-François Pomerol, CEO of Tribun Health. "We're entering the U.S. with a solution that has already proven its value in demanding, high-throughput clinical environments. With CaloPix®, we offer a platform trusted by top-tier institutions, awarded Best in KLAS multiple times -and now validated by the FDA. As the market accelerates toward widespread clinical adoption, we're thrilled to expand our reach and solidify our position as a truly global player." Built for Enterprise, Designed for Performance, Ready for Cloud CaloPix® goes far beyond a traditional image viewer-it's a powerful, all-in-one digital pathology platform tailored for the needs of modern healthcare systems, large hospital networks, and academic institutions. Key capabilities include: Web-based, cloud-ready, zero-footprint architecture-no local installation required High-throughput case management and diagnostic reporting to streamline daily workflowsSeamless integration with LIS and VNA systems for unified data access across the enterpriseBuilt-in telepathology and remote collaboration tools for second opinions and network-wide consultationsArchiving, export, and quality control features to support regulatory compliance and research initiatives Meeting the Moment: Solving U.S. Market Challenges The U.S. faces a growing mismatch between rising pathology case volumes and a shrinking workforce. At the same time, there is a clear push for multi-site collaboration, integrated diagnostics, and precision medicine initiatives. With this FDA clearance, CaloPix® empowers U.S. hospitals and labs to: Digitize pathology workflows at scaleReduce turnaround times and improve reporting accuracyCollaborate remotely across institutionsPrepare for AI adoption with structured, interoperable data Building on our success with public health networks, cancer centers, academic hospitals and private laboratory groups across Europe and Canada, we are now ready to scale in the world's largest healthcare market-the United States. * CaloPix® is CE-marked, Health Canada-approved, and FDA 510(k) cleared. Please refer to the Instructions for Use (IFU) for intended purpose and regulatory indications. About Tribun Health Tribun Health is a global leader in digital pathology, offering award-winning solutions that improve workflow efficiency, diagnostic accuracy, and patient outcomes. We assist hospitals and laboratories in transitioning from glass slide pathology to fully digital solutions, leveraging AI and data-driven technology to enhance precision and reduce turnaround times. Our mission is simple: to ensure every cancer patient receives a timely and informed diagnosis-because every moment counts. By advancing pathology with cutting-edge innovations, we are shaping the future of cancer care. For more information, visit Tribun Health and follow us on LinkedIn and X. SOURCE: Tribun Health press release
Miami Herald
20-05-2025
- Business
- Miami Herald
Tribun Health Achieves FDA Clearance for CaloPix Digital Pathology Platform With Dual Scanner Compatibility
Paving the way for U.S. Market Entry and Global Expansion PARIS, FRANCE / ACCESS Newswire / May 20, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management system, CaloPix®, has received FDA 510(k) clearance for use with two leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360 and the Leica Aperio GT450. This marks the first time a digital pathology software has been cleared with both scanners, representing a major step forward for the U.S. adoption of vendor-agnostic, enterprise-grade solutions. This clearance builds on CaloPix's strong regulatory track record: the solution is CE-marked, Health Canada-approved, and trusted by more than 100 hospitals and laboratories across Europe and Canada. With over 1,000 active users of CaloPix® worldwide, this milestone underscores the platform's scalability, clinical reliability, and rapid adoption across diverse healthcare systems. Now, with FDA clearance secured, Tribun Health is ready to bring its proven enterprise solution to hospitals and labs across the United States. Besides these regulatory achievements, CaloPix® has also been recognized three times as "Best in KLAS" for digital pathology, a global benchmark for excellence in healthcare IT. This prestigious recognition highlights Tribun Health's commitment to customer satisfaction, operational excellence, and product innovation. "This is a major commercial and clinical milestone for us," said Jean-François Pomerol, CEO of Tribun Health. "We're entering the U.S. with a solution that has already proven its value in demanding, high-throughput clinical environments. With CaloPix®, we offer a platform trusted by top-tier institutions, awarded Best in KLAS multiple times -and now validated by the FDA. As the market accelerates toward widespread clinical adoption, we're thrilled to expand our reach and solidify our position as a truly global player." Built for Enterprise, Designed for Performance, Ready for Cloud CaloPix® goes far beyond a traditional image viewer-it's a powerful, all-in-one digital pathology platform tailored for the needs of modern healthcare systems, large hospital networks, and academic institutions. Key capabilities include: Web-based, Cloud ready, zero-footprint architecture-no local installation requiredHigh-throughput case management and diagnostic reporting to streamline daily workflowsSeamless integration with LIS and VNA systems for unified data access across the enterpriseBuilt-in telepathology and remote collaboration tools for second opinions and network-wide consultationsArchiving, export, and quality control features to support regulatory compliance and research initiatives Meeting the Moment: Solving U.S. Market Challenges The U.S. faces a growing mismatch between rising pathology case volumes and a shrinking workforce. At the same time, there is a clear push for multi-site collaboration, integrated diagnostics, and precision medicine initiatives. With this FDA clearance, CaloPix® empowers U.S. hospitals and labs to: Digitize pathology workflows at scaleReduce turnaround times and improve reporting accuracyCollaborate remotely across institutionsPrepare for AI adoption with structured, interoperable data Building on our success with public health networks, cancer centers, academic hospitals and private laboratory groups across Europe and Canada, we are now ready to scale in the world's largest healthcare market-the United States. * CaloPix® is CE mark, HC cleared, FDA cleared. Please refer to IFU for intended use. About Tribun Health Tribun Health is a global leader in digital pathology, offering award-winning solutions that improve workflow efficiency, diagnostic accuracy, and patient outcomes. We assist hospitals and laboratories in transitioning from glass slide pathology to fully digital solutions, leveraging AI and data-driven technology to enhance precision and reduce turnaround times. Our mission is simple: to ensure every cancer patient receives a timely and informed diagnosis-because every moment counts. By advancing pathology with cutting-edge innovations, we are shaping the future of cancer care. For more information, visit Tribun Health and follow us on LinkedIn and X. Contact Information Andreia Beyer VP, Global Marketing & Managing Director, North Americaabeyer@ (416) 565-0474 SOURCE: Tribun Health press release
