Latest news with #ISO13485
Yahoo
3 days ago
- Business
- Yahoo
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO, June 26, 2025--(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. View source version on Contacts Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Tel: (415) 887-2037
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.
Malaysian Reserve
4 days ago
- Business
- Malaysian Reserve
Smart Automation Meets Medical Innovation: ICP DAS & ICP DAS-BMP at Manufacturing World Tokyo 2025
HSINCHU, June 24, 2025 /PRNewswire/ — ICP DAS and its biomedical business unit, ICP DAS-BMP, are pleased to announce their participation in Manufacturing World Tokyo 2025, one of Asia's premier industrial trade shows, held from July 9–11, 2025, at Makuhari Messe, Chiba, Japan. ICP DAS will showcase its latest advancements in energy management, industrial automation, and IoT integration. Highlights include the PM series smart power meters, PMC series intelligent controllers, and IoTstar cloud management software—tools that help enterprises monitor and optimize energy use. Also featured will be remote I/O modules, as well as the tGW series Modbus TCP/RTU gateways, tSH series serial port converters, and DL-10 series data loggers—offering scalable solutions for industrial environments. ICP DAS-BMP will present its growing portfolio of medical-grade TPU (thermoplastic polyurethane) materials for short-term use and implantation periods of up to 90 days. The highlight is the Engineering Arothane™ EARP-35X2 series, an aromatic TPU developed as an auxiliary material for orthodontic treatment. Known for its mechanical strength, dimensional stability, and excellent biocompatibility, it ensures dependable performance in healthcare. Also on display will be TPU pellets specifically tailored for invasive catheters and stents, guidewire coatings, Luer-Lock connectors, and radiopaque medical devices. With excellent processability, mechanical properties, and ISO 10993 compliance, they offer flexible material solutions for a wide range of medical product development needs. Drawing on three decades of automation expertise from ICP DAS, ICP DAS-BMP integrates material science with smart manufacturing. Its ISO 13485 certification and dedicated laboratories ensure strict quality control and responsive support, including small-quantity custom orders. Visit ICP DAS and ICP DAS-BMP at Hall 4, Booth No. 22-39, to explore solutions driving smart factories and healthcare innovation. About ICP DAS and ICP DAS-BMP Founded in 1993, ICP DAS is a global leader in industrial automation, delivering solutions for Industry 4.0 and the Industrial Internet of Things (IIoT). Its hardware and software offerings help businesses boost productivity, energy efficiency, and data connectivity. Its biomedical business unit, ICP DAS-BMP, specializes in medical-grade TPU development and manufacturing. With ISO 13485 certification, advanced laboratories, and smart factory capabilities, it delivers high-performance TPU materials that meet the demands of medical applications. Together, the two companies serve industrial and biomedical markets with flexibility and quality. For more information, visit and
Korea Herald
4 days ago
- Business
- Korea Herald
Smart Automation Meets Medical Innovation: ICP DAS & ICP DAS-BMP at Manufacturing World Tokyo 2025
HSINCHU, June 24, 2025 /PRNewswire/ -- ICP DAS and its biomedical business unit, ICP DAS-BMP, are pleased to announce their participation in Manufacturing World Tokyo 2025, one of Asia's premier industrial trade shows, held from July 9–11, 2025, at Makuhari Messe, Chiba, Japan. ICP DAS will showcase its latest advancements in energy management, industrial automation, and IoT integration. Highlights include the PM series smart power meters, PMC series intelligent controllers, and IoTstar cloud management software—tools that help enterprises monitor and optimize energy use. Also featured will be remote I/O modules, as well as the tGW series Modbus TCP/RTU gateways, tSH series serial port converters, and DL-10 series data loggers—offering scalable solutions for industrial environments. ICP DAS-BMP will present its growing portfolio of medical-grade TPU (thermoplastic polyurethane) materials for short-term use and implantation periods of up to 90 days. The highlight is the Engineering Arothane™ EARP-35X2 series, an aromatic TPU developed as an auxiliary material for orthodontic treatment. Known for its mechanical strength, dimensional stability, and excellent biocompatibility, it ensures dependable performance in healthcare. Also on display will be TPU pellets specifically tailored for invasive catheters and stents, guidewire coatings, Luer-Lock connectors, and radiopaque medical devices. With excellent processability, mechanical properties, and ISO 10993 compliance, they offer flexible material solutions for a wide range of medical product development needs. Drawing on three decades of automation expertise from ICP DAS, ICP DAS-BMP integrates material science with smart manufacturing. Its ISO 13485 certification and dedicated laboratories ensure strict quality control and responsive support, including small-quantity custom orders. Visit ICP DAS and ICP DAS-BMP at Hall 4, Booth No. 22-39, to explore solutions driving smart factories and healthcare innovation. About ICP DAS and ICP DAS-BMP Founded in 1993, ICP DAS is a global leader in industrial automation, delivering solutions for Industry 4.0 and the Industrial Internet of Things (IIoT). Its hardware and software offerings help businesses boost productivity, energy efficiency, and data connectivity. Its biomedical business unit, ICP DAS-BMP, specializes in medical-grade TPU development and manufacturing. With ISO 13485 certification, advanced laboratories, and smart factory capabilities, it delivers high-performance TPU materials that meet the demands of medical applications. Together, the two companies serve industrial and biomedical markets with flexibility and quality.
Business News Wales
18-06-2025
- Health
- Business News Wales
Llusern Scientific Speeding Up Infection Diagnosis with Welsh Innovation Support
Llusern Scientific is developing rapid diagnostic tests to transform how urinary tract infections are diagnosed and treated. With targeted support from the Welsh Government's Innovation team, the company, which is based at Cardiff Edge Business Park, is bringing its first product to market. It is set to pave the way for faster diagnosis, better patient outcomes and reduced antibiotic misuse. Established in 2020 as a spin-out from the University of South Wales, the company set out to address a major health challenge. Urinary infections affect more than 100 million people worldwide each year. Its portable, easy-to-use molecular diagnostic device delivers accurate results within 35 minutes, giving clinicians fast and reliable information. The company has now announced that it has been awarded ISO 13485 certification for its Lodestar DX testing system, a rapid molecular diagnostic platform for urinary tract infections (UTIs). Dr Emma Hayhurst, co-founder and CEO of Llusern Scientific, said: 'When we founded Llusern Scientific, we were on a mission to make a positive difference in healthcare by developing a point-of-care diagnostic that would enable us to improve antimicrobial stewardship. Achieving ISO 13485 certification is a major milestone in our mission because it demonstrates that we have built a manufacturing facility to world-class standards. 'Not only does our Lodestar UTI testing system help a clinician decide whether or not to prescribe an antibiotic, but it will also identify the bacterial cause of the UTI. This enables clinicians to quickly target the right bug with the right treatment to save lives. Now we have ISO 13485 certification, our next goal is to achieve IVDR certification to further expand the market potential for our innovative molecular diagnostic globally.' There are more than 400 million UTI cases globally each year, of which around 90% are women. According to the Sepsis Trust approximately 15-30% of sepsis cases are caused by a UTI. Research has shown that antibiotics are overprescribed by as much as two times for UTIs leading to them being a major driver of antimicrobial resistance (AMR). As well as providing guidance on the best treatment option, Lodestar DX also provides a clear 'rule-out' decision where antibiotics are not necessary, helping to reduce AMR through antibiotic stewardship. ISO 13485 certification is a crucial regulatory step for marketing medical devices globally, as it demonstrates that a manufacturer has a robust Quality Management System in place, showing commitment to patient safety, regulatory compliance, and consistent product quality. Llusern is preparing for commercial launches across India and the Middle East and North Africa region this year, and the US in 2026. The company has received a range of targeted support from the Welsh Government's Innovation team, including SMART Flexible Innovation Support (SFIS), expert design assistance and intellectual property (IP) strategy development—each playing a vital role in advancing the technology and preparing for commercial scale-up. Initial SFIS support in early 2024 enabled the team to develop a clear innovation plan, setting out priorities for product improvements, new clinical applications and growth. A second SFIS award in September 2024 has since supported the delivery of this plan, while design and IP interventions have strengthened its route to market. As a result, Welsh Government innovation support has helped Llusern Scientific to: Enhance its existing diagnostic platform, making it suitable for use in a wider range of clinical settings. Develop a new unique test panel design, addressing contamination risks and improving ease of use for non-laboratory settings. Strengthen its IP portfolio through a comprehensive audit and actionable recommendations, boosting investor confidence. Expand research and development facilities at Cardiff Edge Business Park. Advance collaborations with Public Health Wales and NHS partners, supporting clinical validation and real-world evidence generation. While Agile Cymru funding has provided valuable opportunities to explore international markets, the company's core innovation progress has been driven by targeted support from the Welsh Government's Innovation team.
