Latest news with #MedicalDeviceRegulation
Euractiv
2 days ago
- Health
- Euractiv
Commission study warns rules and mistrust stall AI in healthcare
A new European Commission report says artificial intelligence (AI) could help deliver quality healthcare to an ageing population, but warns that complex regulations and a lack of trust are slowing uptake. 'Looking for a smart and fun summer read about Artificial Intelligence in healthcare? Check this out!' joked a digital health policy officer at the Commission's DG Sante in a recent LinkedIn post, pointing to the newly published 241-page Study on the Deployment of AI in Healthcare. While the fun parts might be hard to find, the report – published just in time for the summer holidays – provides a comprehensive overview of the topic, including its opportunities and challenges. Between 2015 and 2024, EU research projects on AI in health received €3.5 billion in funding, averaging €6.73 million per project – figures laid out in the study that give a picture of how heavily the bloc is already invested in the field. Over the same period, AI-related healthcare patents increased from 22 in 2017 to 118 in 2023, and clinical trials of AI- and machine learning–enabled medical devices rose from six in 2015 to 657 in 2024. The report found that AI is already being used in hospitals worldwide to automate tasks such as clinical documentation, improve diagnostic accuracy and speed, and enable personalised treatments – with demonstrable impacts on care. Such tools are urgently needed as health systems face rising demand from an ageing population increasingly affected by chronic disease, alongside staff shortages and rising costs. However, developers and implementers must navigate overlapping rules, including the Artificial Intelligence Act, the General Data Protection Regulation (GDPR), the Medical Device Regulation and the planned European Health Data Space. "While robust, the regulatory environment governing AI in healthcare presents complexities that may contribute to hesitancy in AI deployment," reads a summary of the report. The study points to ideas such as setting up interdisciplinary AI governance committees in clinical settings to help oversee compliance and streamline decision-making. It also mentions measures like comprehensive data governance frameworks, robust storage policies, encryption methods and privacy-by-design technologies to address security concerns. It further notes that boosting digital health literacy and technical skills among healthcare professionals and patients could help build trust in the reliability and ethical implications of AI. "Through strategic action and a commitment to overcoming deployment challenges, the EU can position itself as a global leader in AI-driven healthcare innovation," the report concludes. (de)
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 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@
Business Wire
25-06-2025
- Business
- Business Wire
Glaukos Announces EU MDR Certification for iStent infinite ® and Other Leading MIGS Therapies
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received European Union (EU) Medical Device Regulation (MDR) certification for iStent infinite ®, along with several of its other leading micro-invasive glaucoma surgery (MIGS) technologies, including iStent inject ® W. Glaukos' iStent ® trabecular micro-bypass stenting platform primarily involves the insertion of a micro-scale surgical devices designed to reduce intraocular pressure by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma. "We are pleased to receive these important regulatory clearances for our leading trabecular micro-bypass stenting devices, marking our company's first approvals under the new EU regulatory framework,' said Thomas Burns, Glaukos chairman and chief executive officer. 'These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally. We are eager to commence commercial launch activities for these novel MIGS therapies over the coming months." These certifications affirm that iStent infinite and iStent inject W meet the stringent requirements of the EU MDR – a new, robust framework established to ensure high standards of quality, safety and effectiveness for medical devices marketed in the EU. Glaukos is proud to be the corporate pioneer and global market leader in MIGS, with its family of iStent technologies supported by nearly 400 peer-reviewed publications, 20 plus years of clinical and commercial experience and more than one million iStent devices implanted worldwide since its inception. The company believes it offers the industry's most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting its goal to provide a full range of options to fit surgeons' individual glaucoma treatment algorithms that offer the most favorable short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures. About Glaukos Glaukos ( is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, Glaukos commenced commercial launch activities for iDose ® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rarely diagnosed corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases. About iStent infinite ® Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. Contraindications: The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI Information: The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. Adverse Events: The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events. For more information, visit
Yahoo
25-06-2025
- Business
- Yahoo
Glaukos Announces EU MDR Certification for iStent infinite® and Other Leading MIGS Therapies
Regulatory Clearances Support Glaukos' Plans to Advance and Accelerate its Interventional Glaucoma Initiatives Globally Marks the Company's First Regulatory Clearances Under the New EU Regulatory Framework ALISO VIEJO, Calif., June 25, 2025--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received European Union (EU) Medical Device Regulation (MDR) certification for iStent infinite®, along with several of its other leading micro-invasive glaucoma surgery (MIGS) technologies, including iStent inject® W. Glaukos' iStent® trabecular micro-bypass stenting platform primarily involves the insertion of a micro-scale surgical devices designed to reduce intraocular pressure by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma. "We are pleased to receive these important regulatory clearances for our leading trabecular micro-bypass stenting devices, marking our company's first approvals under the new EU regulatory framework," said Thomas Burns, Glaukos chairman and chief executive officer. "These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally. We are eager to commence commercial launch activities for these novel MIGS therapies over the coming months." These certifications affirm that iStent infinite and iStent inject W meet the stringent requirements of the EU MDR – a new, robust framework established to ensure high standards of quality, safety and effectiveness for medical devices marketed in the EU. Glaukos is proud to be the corporate pioneer and global market leader in MIGS, with its family of iStent technologies supported by nearly 400 peer-reviewed publications, 20 plus years of clinical and commercial experience and more than one million iStent devices implanted worldwide since its inception. The company believes it offers the industry's most comprehensive offering of minimally-invasive, tissue-sparing glaucoma solutions, supporting its goal to provide a full range of options to fit surgeons' individual glaucoma treatment algorithms that offer the most favorable short- and long-term benefit-to-risk calculus at every stage of disease progression, from ocular hypertension through refractory disease, and in both combo-cataract and standalone procedures. About Glaukos Glaukos ( is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, Glaukos commenced commercial launch activities for iDose® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rarely diagnosed corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases. About iStent infinite® Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. Contraindications: The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI Information: The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. Adverse Events: The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events. For more information, visit View source version on Contacts Chris LewisVice President, Investor Relations & Corporate Affairs(949) 481-0510clewis@
