Latest news with #CEMark
Time of India
09-07-2025
- Health
- Time of India
Dozee Secures CE Mark, Unlocks Global Markets for Remote Patient Monitoring and Early Warning Systems
Bengaluru: Health-tech innovator Dozee announced that it has secured CE Mark under the European Union Medical Device Regulation (EU MDR 2017/745), a gold standard for medical device safety and efficacy. Already a recipient of US FDA 510(k) clearance for its proprietary contactless vital signs monitoring technology, Dozee's dual international certifications now firmly establish it as a globally trusted name in Remote Patient Monitoring (RPM) and Early Warning Systems (EWS)—two of the fastest-growing pillars in digital healthcare. 'CE Mark positions Dozee among a select group of global health-tech innovators whose solutions meet stringent international standards while driving real-world impact,' said Gaurav Parchani, CTO and Co-founder of Dozee. 'We're building world-class infrastructure to provide access to quality healthcare to billions globally. Every signal captured, every insight generated, is designed to drive timely intervention and save lives.' The CE Mark, granted by leading Notified Body TÜV SÜD, enables Dozee to market its products across more than 30 countries in the European Economic Area (EEA). It affirms the company's compliance with stringent regulatory benchmarks for safety, efficacy, clinical validation, and quality management. Dozee's Class IIb MDR-certified system uses contactless sensors and AI-driven algorithms to track vital signs including heart rate, respiratory rate, SpO₂, blood pressure, temperature, and patient movement. These real-time, continuous insights allow healthcare teams to detect clinical deterioration early—helping reduce Code Blue events, prevent ICU admissions, and enhance overall patient outcomes.
One 3 Sport
02-07-2025
- Health
- One 3 Sport
ليس وسام أبو علي.. عرض خليجي يهدد استمرار نجم الأهلي
by cradmin July 2, 2025 0 379 Share 0 Bengaluru, India – July 02, 2025 – Dozee , a fast-growing player in Remote Patient Monitoring (RPM) and Early Warning Systems (EWS), has secured a major global milestone: CE Mark under the European Union's Medical Device Regulation (EU MDR 2017/745) . This milestone underscores Dozee's steadfast commitment to clinical safety, product excellence, and world-class regulatory compliance — affirming that clinically-validated innovations from India can set the benchmark on the global stage . The CE Mark is more than a regulatory requirement—it is a symbol of clinical trust, product maturity, and global readiness. Building on its earlier FDA clearance, this dual-certification reinforces Dozee's credibility as a clinically validated, internationally compliant solution, ready to transform care delivery across diverse healthcare ecosystems worldwide. ' CE Mark positions Dozee among a select group of global health-tech innovators whose solutions meet stringent international standards while driving real-world impact.' said Gaurav Parchani, CTO & Co-founder of Dozee. ' We're building world class infrastructure to provide access to quality healthcare to billions globally. Every signal captured, every insight generated, is designed to drive timely intervention and save lives . That's how we turn engineering into impact—by designing systems trusted across borders, and built for humanity.' The CE Mark opens access to over 30 countries across the European Economic Area (EEA) and catalyzes Dozee's vision to make continuous, remote patient monitoring and early warning systems a global standard. Dozee's vital signs monitoring system—classified as Class IIb under MDR —measures and monitors vital signs such as: Heart Rate(HR), Respiration Rate(RR), Non-invasive Blood Pressure, Temperature, Oxygen Saturation (SpO₂) and Patient Movement. These are tracked seamlessly using contactless sensors and advanced algorithms, enabling healthcare providers to detect early signs of patient deterioration, intervene in time, and significantly improve clinical outcomes. The CE Mark was awarded by TÜV SÜD, a globally respected Notified Body, after comprehensive assessments of Dozee's quality management system , technical documentation , and clinical validation . It attests to the solution's robustness in real-world settings and its readiness to support healthcare systems across care settings around the world. Dozee is transforming patient care at scale. With a presence in 300+ hospitals and care centers across India, the USA, Africa, and the UAE, it empowers care teams to enhance efficiency, reduce Code Blue events, enable early intervention, reduce length of stay in critical care, and elevate the overall patient experience—driving better outcomes and raising the standard of care worldwide. In 2022, Dozee received US-FDA 510(k) clearance for its proprietary contactless vital signs (VS) monitoring technology. With the CE Mark, Dozee is set to strengthen the global infrastructure for connected, AI-powered healthcare. For Media Queries, Please contact: Ms. Pratha Bhagat +91 7378781427 Pratha@ Share 0
Business Wire
02-07-2025
- Business
- Business Wire
Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program. 'We are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that TÜV-SÜD, our Notified Body, has completed their review of the clinical module and transferred information to the State Institute for Drug Control (SÚKL) in the Czech Republic, for consultation. Reaching this meaningful milestone enables SÚKL to initiate its review of the active pharmaceutical ingredient (API) module. In addition, as we had anticipated, SÚKL has agreed to review our submission as the Competent Authority,' said William 'Obi' Greenman, Cerus' president and chief executive officer. 'We are looking forward to working collaboratively with both TÜV-SÜD and SÚKL to facilitate the completion of the review process for our enhanced CE Mark submission for the INTERCEPT RBC system.' Importantly, the clinical module that has now been successfully reviewed by TÜV-SÜD included the positive results from the U.S. Phase 3 ReCePI clinical trial, expanding Cerus' CE Mark submission to cover all patient indications for RBC transfusion. SÚKL will now review the API module in the application, before the submission goes back to TÜV-SÜD for completion of manufacturing facility audits and certification prior to CE Mark decision. Under the European Medical Device Regulation (MDR), the CE Mark submission review process for Class III devices such as the INTERCEPT RBC system is rigorous and involves both Notified Bodies and Competent Authorities. The Notified Body evaluates multiple aspects including the manufacturer's quality system and technical documentation to ensure adherence to European regulations. The Competent Authority is responsible for reviewing the active pharmaceutical ingredient manufacturing and safety. ABOUT CERUS Cerus Corporation is dedicated solely to safeguarding the world's blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE Mark and FDA approval for these two blood components. In the U.S., the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit and follow us on LinkedIn. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation. Forward-Looking Statements Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus' INTERCEPT RBC programs and prospects, including statements relating to the anticipated completion of Cerus' CE Mark application review process for the INTERCEPT RBC system and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: the uncertain and time-consuming development and regulatory process, including the risks that (a) Cerus' submission to SÚKL may not satisfactorily address the issues in its prior submission that prevented CE Mark approval for the INTERCEPT RBC system, (b) Cerus may be unable to meet the additional applicable requirements to complete the CE Mark application review process for INTERCEPT RBCs in a timely manner or at all, and that Cerus may otherwise determine to substantially delay or abandon its efforts to seek CE Mark approval of the INTERCEPT RBC system, and (c) Cerus may otherwise be unable to obtain any regulatory approvals of the INTERCEPT RBC system in a timely manner or at all; Cerus' ability to maintain an effective, secure manufacturing supply chain, including the risk that Cerus may be required to engage and validate a new supplier for key components of the INTERCEPT RBC system, which would substantially delay the CE Mark application review process for INTERCEPT RBCs and/or a review decision thereon; commercialization and market acceptance of, and customer demand for, the INTERCEPT RBC system, if approved; successfully launching a new commercial product; Cerus' ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System, including the INTERCEPT RBC system, is safe, effective and economical; future opportunities and plans, including the uncertainty of Cerus' future capital requirements and the sufficiency of its cash resources and anticipated funding under its agreements with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response; as well as other risks detailed in Cerus' filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' in Cerus' Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 1, 2025. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Business Standard
02-07-2025
- Health
- Business Standard
Dozee Secures CE Mark, Cementing Its Global Presence in Remote Patient Monitoring (RPM) and Early Warning Systems (EWS) Market
VMPL Bengaluru (Karnataka) [India], July 2: Dozee, a fast-growing player in Remote Patient Monitoring (RPM) and Early Warning Systems (EWS), has secured a major global milestone: CE Mark under the European Union's Medical Device Regulation (EU MDR 2017/745). This milestone underscores Dozee's steadfast commitment to clinical safety, product excellence, and world-class regulatory compliance--affirming that clinically-validated innovations from India can set the benchmark on the global stage. The CE Mark is more than a regulatory requirement--it is a symbol of clinical trust, product maturity, and global readiness. Building on its earlier FDA clearance, this dual-certification reinforces Dozee's credibility as a clinically validated, internationally compliant solution, ready to transform care delivery across diverse healthcare ecosystems worldwide. "CE Mark positions Dozee among a select group of global health-tech innovators whose solutions meet stringent international standards while driving real-world impact." said Gaurav Parchani, CTO & Co-founder of Dozee. "We're building world class infrastructure to provide access to quality healthcare to billions globally. Every signal captured, every insight generated, is designed to drive timely intervention and save lives. That's how we turn engineering into impact--by designing systems trusted across borders, and built for humanity." The CE Mark opens access to over 30 countries across the European Economic Area (EEA) and catalyzes Dozee's vision to make continuous, remote patient monitoring and early warning systems a global standard. Dozee's vital signs monitoring system--classified as Class IIb under MDR--measures and monitors vital signs such as: Heart Rate(HR), Respiration Rate(RR), Non-invasive Blood Pressure, Temperature, Oxygen Saturation (SpO₂) and Patient Movement. These are tracked seamlessly using contactless sensors and advanced algorithms, enabling healthcare providers to detect early signs of patient deterioration, intervene in time, and significantly improve clinical outcomes. The CE Mark was awarded by TUV SUD, a globally respected Notified Body, after comprehensive assessments of Dozee's quality management system, technical documentation, and clinical validation. It attests to the solution's robustness in real-world settings and its readiness to support healthcare systems across care settings around the world. Dozee is transforming patient care at scale. With a presence in 300+ hospitals and care centers across India, the USA, Africa, and the UAE, it empowers care teams to enhance efficiency, reduce Code Blue events, enable early intervention, reduce length of stay in critical care, and elevate the overall patient experience--driving better outcomes and raising the standard of care worldwide. In 2022, Dozee received US-FDA 510(k) clearance for its proprietary contactless vital signs (VS) monitoring technology. With the CE Mark, Dozee is set to strengthen the global infrastructure for connected, AI-powered healthcare. For Media Queries, Please contact: Ms. Pratha Bhagat +91 7378781427 Pratha@
Yahoo
01-07-2025
- Business
- Yahoo
ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application
FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United States CE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announced the submission of two major regulatory applications for its ARC-EX System. The Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking clearance to expand its indication for home use. In parallel, ONWARD has filed an application with the notified body for CE Mark certification in accordance with the European Union Medical Device Regulation (MDR) to enable commercialization of the ARC-EX System in the EU. Completed in June, these submissions represent significant milestones as the Company advances its mission to bring breakthrough therapies to people with SCI around the world. The ARC-EX System is the first and only FDA-cleared technology indicated to improve hand sensation and strength after SCI. Following the successful initial phase of its US launch to clinics, ONWARD is pursuing FDA clearance to expand marketing of the ARC-EX System for use at home. Strong early demand and positive feedback from users suggest the Company is on track to meet its 2025 expectations. Clearance for home use would significantly broaden access to this innovative technology. Simultaneously, ONWARD is preparing for the commercialization of the ARC-EX System through its CE Mark submission. Once approved, the ARC-EX System would be available in the European Union and other countries recognizing CE Marking. 'These two submissions are further evidence of our ability to execute against our innovation roadmap,' said Dave Marver, Chief Executive Officer of ONWARD Medical. 'Gaining regulatory authorization for ARC-EX in Europe and broadening the ARC-EX label in the US will greatly expand the market while offering improved and more convenient access for those with SCI.' Earlier this year, ONWARD also announced the publication of positive results from the investigator-sponsored Pathfinder2 Study in Neuromodulation: Technology at the Neural Interface. This peer-reviewed paper further expands the body of clinical evidence supporting the ARC-EX System. The one-year trial demonstrated that ARC-EX Therapy combined with activity-based rehabilitation delivered significant functional improvements when administered to people with SCI in community-based rehabilitation centers. Participants experienced continued gains in upper body strength, trunk control, and balance after one year of treatment, with no plateau in therapeutic benefit1. About ONWARD Medical ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities. Building on more than a decade of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company has developed ARC Therapy, which has been awarded ten Breakthrough Device Designations from the US FDA. The Company's ARC-EX System is cleared for commercial sale in the US. In addition, the Company is developing an investigational implantable system called ARC-IM with and without an implanted brain-computer interface (BCI). Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, visit and connect with us on LinkedIn. To be kept informed about the Company's technologies, research studies, and the availability of therapies in your area, please complete this webform. For Media Inquiries: Sébastien Cros, VP communications media@ For Investor Inquiries: investors@ Disclaimer Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited. 1ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive). Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial in to access your portfolio
