Latest news with #ISO13485:2016
Yahoo
2 days ago
- Business
- Yahoo
ForSight Robotics raises $125M for cataract surgery platform
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. ForSight Robotics has raised $125 million as it prepares for first-in-human robotic cataract surgery clinical trials this year. The Israel-based company said this week the funds will support the next phase of growth in the development of its Oryom platform, the world's first robotic surgery platform for cataracts and other eye diseases. Participants in the Series B funding round include Eclipse, Intuitive Surgical co-founder Fred Moll, Adani Group and Reiya Ventures, among other investors. ForSight is scaling up, having identified a need to expand patient access to eye surgery amid a declining number of ophthalmologists and growing demand for vision treatment. The company cited a forecast from researchers at Vanderbilt University pointing to a 12% decline in ophthalmologists by 2035, alongside a projected 24% increase in demand. Joseph Nathan, ForSight co-founder and chief medical officer, said in a statement that the urgent global need presents an 'immense' opportunity for the company. 'We see ophthalmology as the next frontier in the robotics revolution – much like general surgery was before the rise of Intuitive Surgical,' said Nathan. Starting with cataract surgery, ForSight's platform aims to offer surgeons the dexterity, maneuverability and ergonomics to provide precise and consistent ophthalmic procedures, according to the company. The platform is designed to allow surgeons to navigate complex angles to reach any point in the eye, enabling glaucoma and retinal surgical treatment. 'The company is tapping into a massive, underserved market,' said Eclipse partner Seth Winterroth. ForSight said more than two dozen ophthalmic surgeons have successfully completed hundreds of procedures on animal eye models using its platform. In February, it received ISO 13485:2016 certification, an international benchmark for quality management systems in the medical device industry. The company completed a $55 million funding round in 2022, and has raised a total of $195 million to date. Recommended Reading 4 robotic surgery trends to watch in 2025 Sign in to access your portfolio
Business Wire
3 days ago
- Business
- Business Wire
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO--(BUSINESS WIRE)-- Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor. 'This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company,' said Paul Molloy, CEO of Avvio Medical. 'Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations.' He added, 'The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it.' The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals.
Yahoo
16-06-2025
- Business
- Yahoo
TekniPlex opens facility in Wisconsin
TekniPlex Healthcare has initiated production at its newly established 200,000ft² facility in Madison, Wisconsin. Located at 6002 Femrite Drive, this site is expected to enhance the company's Barrier Protection Systems business. According to the company, the new location seeks to merge manufacturing technologies with expertise in materials science. This strategy aims to broaden capabilities and improve access to protective solutions throughout North America and internationally. This facility will help boost TekniPlex Healthcare's support for medical device and pharmaceutical firms. It is designed to ensure 'reliable' access to sterile barrier packaging for hospitals, outpatient surgical centres, laboratories, and patients, stated the company. The Madison plant has received ISO 13485:2016 quality management system certification. As TekniPlex Healthcare's second site in Madison, it will concentrate on creating coated and printed solutions. These products are crucial for safeguarding medical devices and wound care products from contaminants, ultimately enhancing patient outcomes. The new plant is equipped with modern manufacturing infrastructure, including an air knife coater, added the company. This machinery will help the company boost the supply of coated Tyvek and heat-seal coated reinforced papers for various sterilisation barrier applications. Furthermore, the facility features a wide-width eight-colour high-definition flexographic printing press. This technology enables TekniPlex Healthcare to fulfil stringent healthcare printing requirements while maintaining a near-zero waste manufacturing process. Sustainability is a primary focus for the new facility, which has adopted an eco-friendly design approach. The company states that at least 95% of the waste produced by the facility is recyclable. Looking forward, the facility has plans for future expansion opportunities. These include the addition of a second flexographic printer, a cantilevered slitter rewinder, and a reversible salvage rewinder. TekniPlex Healthcare CEO Suj Mehta said: 'Our new flagship facility exemplifies TekniPlex Healthcare's mission of improving patient care through solutions that protect, preserve, and perform. The products manufactured here directly impact patients' lives. 'As a dedicated hub, the site not only expands our capacity and provides customers with supply chain assurances, but also serves as a knowledge base to build upon and maximise our leadership in barrier protection materials science.' In October 2024, TekniPlex Healthcare introduced its new bio-based medical-grade polyvinyl chloride compounds. "TekniPlex opens facility in Wisconsin" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
09-06-2025
- Business
- Yahoo
Sesen Launches with a Singular Mission: Advancing Life Sciences Globally Through Specialized Language Solutions
BOSTON, June 09, 2025--(BUSINESS WIRE)--Today marks the official launch of Sesen, a next-generation language services company purpose-built to meet the complex demands of the life sciences industry. Specializing exclusively in translation, localization, and AI-enhanced linguistic solutions for pharmaceutical, biotechnology, medical device, CRO, and regulatory organizations, Sesen combines industry expertise with cutting-edge technology to deliver fast, accurate, and fully compliant multilingual communications across 150+ languages. Built by industry veterans, Sesen is redefining how life sciences companies manage language workflows, from clinical trial documentation and regulatory labeling to patient communications and digital health platforms. At the core of its offering is SesenGPT, a proprietary AI engine trained on life sciences terminology and optimized for medical and regulatory content. Key Capabilities Include: Regulatory-compliant translations aligned with EMA, FDA, and PMDA guidelines ISO 17100, ISO 9001:2015, and ISO 13485:2016 certified quality management AI-enabled hybrid workflows for clinical trial translations, pharmacovigilance, and labeling Native linguists and MD/PhD medical reviewers for domain-specific accuracy Scalable language solutions integrated with sponsor CMS and eTMF systems "Life sciences innovation is increasingly global, but language remains a critical barrier," said Dr. Vladimir Misik, VP of Global Clinical Trial Strategy. "We launched Sesen to solve this challenge with unmatched specialization, seamless technology integration, and the linguistic precision this industry demands." Diego Di Leva, Sesen's VP of Global Operations, and a certified ISO 9001 and ISO 13485 auditor, added: "At Sesen, language quality is not an afterthought, it's built into the DNA of every project. Our quality assurance framework is grounded in international standards and supported by linguists with deep domain expertise, ensuring every deliverable meets the highest regulatory and scientific expectations." With a growing network of linguists, in-country reviewers, and regulatory consultants, Sesen supports top pharmaceutical and biotechnology companies with on-time, compliant delivery of multilingual assets for product launches, clinical trials, and regulatory submissions. About Sesen Sesen is a specialized language solutions provider exclusively serving the life sciences industry. Focused on clinical, regulatory, and commercial translation, Sesen supports pharmaceutical, biotech, medical device, and CRO clients in 150+ languages. The company combines native linguists, medical professionals, and ISO-certified workflows with proprietary AI technology to deliver faster, more accurate, and compliant content. From clinical trial support to product localization, Sesen enables life sciences organizations to operate with linguistic confidence and regulatory precision. View source version on Contacts Media Contact: Nikki Andrewspress@ Sign in to access your portfolio
Business Wire
09-06-2025
- Business
- Business Wire
Sesen Launches with a Singular Mission: Advancing Life Sciences Globally Through Specialized Language Solutions
BOSTON--(BUSINESS WIRE)--Today marks the official launch of Sesen, a next-generation language services company purpose-built to meet the complex demands of the life sciences industry. Specializing exclusively in translation, localization, and AI-enhanced linguistic solutions for pharmaceutical, biotechnology, medical device, CRO, and regulatory organizations, Sesen combines industry expertise with cutting-edge technology to deliver fast, accurate, and fully compliant multilingual communications across 150+ languages. Built by industry veterans, Sesen is redefining how life sciences companies manage language workflows, from clinical trial documentation and regulatory labeling to patient communications and digital health platforms. At the core of its offering is SesenGPT, a proprietary AI engine trained on life sciences terminology and optimized for medical and regulatory content. Key Capabilities Include: Regulatory-compliant translations aligned with EMA, FDA, and PMDA guidelines ISO 17100, ISO 9001:2015, and ISO 13485:2016 certified quality management AI-enabled hybrid workflows for clinical trial translations, pharmacovigilance, and labeling Native linguists and MD/PhD medical reviewers for domain-specific accuracy Scalable language solutions integrated with sponsor CMS and eTMF systems 'Life sciences innovation is increasingly global, but language remains a critical barrier,' said Dr. Vladimir Misik, VP of Global Clinical Trial Strategy. 'We launched Sesen to solve this challenge with unmatched specialization, seamless technology integration, and the linguistic precision this industry demands.' Diego Di Leva, Sesen's VP of Global Operations, and a certified ISO 9001 and ISO 13485 auditor, added: "At Sesen, language quality is not an afterthought, it's built into the DNA of every project. Our quality assurance framework is grounded in international standards and supported by linguists with deep domain expertise, ensuring every deliverable meets the highest regulatory and scientific expectations." With a growing network of linguists, in-country reviewers, and regulatory consultants, Sesen supports top pharmaceutical and biotechnology companies with on-time, compliant delivery of multilingual assets for product launches, clinical trials, and regulatory submissions. About Sesen Sesen is a specialized language solutions provider exclusively serving the life sciences industry. Focused on clinical, regulatory, and commercial translation, Sesen supports pharmaceutical, biotech, medical device, and CRO clients in 150+ languages. The company combines native linguists, medical professionals, and ISO-certified workflows with proprietary AI technology to deliver faster, more accurate, and compliant content. From clinical trial support to product localization, Sesen enables life sciences organizations to operate with linguistic confidence and regulatory precision.
