Latest news with #EuropeanUnionMedicalDeviceRegulation
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.
Yahoo
27-06-2025
- Business
- Yahoo
Glaukos gains EU certification for iStent infinite and other MIGS devices
Glaukos has secured European Union Medical Device Regulation (EU-MDR) certification for its iStent infinite, along with other micro-invasive glaucoma surgery (MIGS) technologies, including the iStent inject W. According to the company, its iStent trabecular micro-bypass stenting platform predominantly involves the insertion of micro-scale surgical devices intended to minimise intraocular pressure (IOP) with the restoration of pathways of the natural aqueous humor outflow for individuals with glaucoma. Known for creating two patent bypass pathways via the trabecular meshwork, the iStent inject W claims to be one of the smallest medical devices to be implanted in the body of a human. Its design allows for multi-directional flow through Schlemm's canal, offering a micro-invasive approach to glaucoma treatment. The iStent infinite Trabecular Micro-Bypass System Model iS3 is intended to minimise IOP in adults with primary open-angle glaucoma where prior treatments have failed. As the first standalone micro-invasive implantable alternative, the iStent infinite is said to have been tailored to maximise outflow with minimal disruption to natural anatomy, occupying 3% of Schlemm's canal. Glaukos CEO and chairman Thomas Burns said: "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. '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." Last year, the company began commercial launch activities for iDose TR, an intracameral procedural pharmaceutical that provides continuous glaucoma drug therapy inside the eye for extended periods. In 2023, speciality materials and chemical company Celanese entered an agreement with Glaukos for the supply of its VitalDose drug delivery platform. "Glaukos gains EU certification for iStent infinite and other MIGS devices" was originally created and published by Medical Device Network, 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.
Yahoo
22-05-2025
- Business
- Yahoo
ReGelTec's system for disc augmentation gains CE Mark approval
ReGelTec has secured CE Mark approval for the Class III Hydrafil System for disc augmentation, under the European Union Medical Device Regulation (MDR). The approval is based on a clinical trial involving 75 subjects, which revealed that the system's treatment led to significant improvements in disability and pain. According to the findings, an improvement exceeding 80% was observed in Oswestry Disability Index (ODI) scores and a decrease of more than 70% in Numeric Pain Rating Scale scores post-treatment, with sustained results for two years. ReGelTec noted that the system is designed to be an outpatient procedure performed under local anaesthesia. It involves the injection of a permanent hydrogel into a degenerated disc for filling cracks and tears while also recruiting water to restore the disc's natural biomechanics and alleviate pain. Once solidified in the disc, the hydrogel implant helps in distributing the strain and load across the intervertebral segment, enhancing function and decreasing pain signals to the brain. The data that supported this approval also contributed to the US Food and Drug Administration's (FDA) decision to grant an investigational device exemption (IDE) for the company's US pivotal study, HYDRAFIL-D. This single-blinded, 225-patient, randomised, controlled study is actively enrolling subjects across eight sites and aims to support future regulatory approval in the country. The study includes an interim safety analysis scheduled after the first 60 subjects complete their six-month follow-up. ReGelTec's percutaneous hydrogel implant is intended for treating chronic low back pain caused by degenerative disc disease. ReGelTec CEO and co-founder Bill Niland said: 'Receiving CE Mark for the Hydrafil System is another major milestone for ReGelTec. We are leveraging this momentum to drive enrolment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the US and globally.' In June 2023, the company reached an exclusive distribution agreement with BCWorld Healthcare for the system in South Korea. "ReGelTec's system for disc augmentation gains CE Mark approval" was originally created and published by Medical Device Network, 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Health
- Yahoo
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
Clinical data show the percutaneous disc augmentation system generated significant improvements in pain and disability scores through 2-year follow-up BALTIMORE, May 21, 2025--(BUSINESS WIRE)--ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. "Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries," said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. "After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study." More than 1 in 10 U.S. adults suffer from chronic low back pain.1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their 6-month follow-up visit. "Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec," said Bill Niland, Co-Founder and CEO, ReGelTec. "We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally." ABOUT REGELTEC, INC: ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit ______________________________ 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, View source version on Contacts MEDIA CONTACT: Sam ChoinskiPazanga Health Communications(860) 301-5058schoinski@ Sign in to access your portfolio
Business Wire
21-05-2025
- Health
- Business Wire
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
BALTIMORE--(BUSINESS WIRE)-- ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. 'Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries,' said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. 'After following 35 patients treated with HYDRAFIL over the last three years, I've witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability. HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study.' More than 1 in 10 U.S. adults suffer from chronic low back pain. 1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease 2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their 6-month follow-up visit. 'Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec,' said Bill Niland, Co-Founder and CEO, ReGelTec. 'We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally.' ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233,
