Latest news with #EUMDR
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.
Scotsman
28-06-2025
- Health
- Scotsman
Webinar welcomes national standards body for support on navigating new legislation
A free webinar has encouraged medical device innovators to learn more about new Post-Market Surveillance (PMS) legislation and how to successfully navigate it. Sign up to our Scotsman Money newsletter, covering all you need to know to help manage your money. Sign up Thank you for signing up! Did you know with a Digital Subscription to The Scotsman, you can get unlimited access to the website including our premium content, as well as benefiting from fewer ads, loyalty rewards and much more. Learn More Sorry, there seem to be some issues. Please try again later. Submitting... Hosting the educational session on Wednesday, June 25 – entitled ' The new Post-Market Surveillance legislation for medical devices - what you need to know' – formal NHS Scotland partner InnoScot Health believes it was a key opportunity to better understand the changes for Great Britain. The changes are intended to improve the safety of medical devices – including in vitro diagnostics (IVD) and active implantable devices – while providing certainty for manufacturers. Advertisement Hide Ad Advertisement Hide Ad Part of wider regulatory reform, the amended regulation will, the Medicines and Healthcare products Regulatory Agency (MHRA) says, 'introduce clearer and more risk-proportionate PMS requirements'. Head of Innovation, Robert Rea, InnoScot Health The 'lunch and learn' webinar was presented by Head of Regulatory Affairs Elaine Gemmell, who provided an overview of the complexities of the current landscape and outlined why it is vital to receive professional advice in order to navigate it successfully. She was joined by guest speakers from The British Standards Institution (BSI) – Damon Williams, Sales Manager – Medical Devices, UK & Ireland, and Umar Butt, Business Development Manager, North UK and Ireland. The national standards body of the United Kingdom, BSI is recognised through a Memorandum of Understanding with the UK Government, producing technical standards on a wide range of products and services. Advertisement Hide Ad Advertisement Hide Ad They spoke on the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR and anticipated changes. User (UGC) Submitted Elaine said: 'Our June webinar was an opportunity to gain a more in-depth understanding of what is crucial new legislation for medical device manufacturers. 'Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal. 'But clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards. Advertisement Hide Ad Advertisement Hide Ad 'In response, we now have an important amendment this month and manufacturers are advised to learn more. 'We believe attendees found it useful and instructive in taking practical steps.' The webinar was rounded off by an opportunity to ask questions of the speakers. The medical device industry has experienced unprecedented growth over recent years, and changes to the regulatory landscape mean it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.
Yahoo
09-06-2025
- Health
- Yahoo
Newel Health obtains EU MDR for blood pressure management platform
Amid the growing prevalence of hypertension in the EU, Italian health tech Newel Health has secured a CE mark for its Amicomed platform under the EU's Medical Device Regulation (EU MDR), enabling it to support the management of high blood pressure. Compatible with blood pressure monitors including Apple Health and Google Fit, the smartphone app-based platform captures structured blood pressure data and translates it into 'clinically meaningful' insights, Newel Health stated, and offers personalised feedback towards high blood pressure management based on real-world data. The platform's features include medication reminders to improve adherence, and personalised lifestyle and dietary recommendations based on a user's clinical profile. The capabilities are supported by Amicomed's architecture. Developed by Newel Health, the proprietary platform uses artificial intelligence (AI)-based predictive models to improve behavioural segmentation, sustain engagement, and adapt interventions based on an individual's profile. A 2023 report by GlobalData forecasts that AI platforms in healthcare will reach a valuation of $18.8bn by 2027. Newel Health CEO, Ervin Ukaj commented: "We designed Amicomed to offer a digital therapy that fits into people's everyday lives, supporting them, day by day, in managing hypertension. "The MDR certification confirms the strength of our platform and the reliability of our regulatory approach.' Ukaj added that Newel intends to pursue 'scalable growth' by seeking further partnerships with public and private healthcare stakeholders. Systemic hypertension is a key risk factor for chronic disease burden, and a known precursor for cardiovascular diseases (CVDs) including atherosclerotic cardiovascular disease, with research indicating that hypertension in the EU is on the rise. A European Commission (EC) survey from 2019 found that 22% of individuals aged 15 and above reported having received a high blood pressure diagnosis from a medical professional, while a 2023 report by the World Health Organization (WHO) estimates that the number of adults with hypertension in the European region and the Americas rose from 302 million in 1990 to 427 million in 2019 – reflecting a 41% rise. All medical device manufacturers marketing products in the EU must fall in line with the dictates of the EU MDR regulation by 2028. Introduced in 2017 and coming into its 'first phase' of effect in 2021, the EU MDR is promulgated as a means to centralise competencies at the EU level. While well-intentioned, some observers have deemed the regulation's roll out a 'disaster', with concerns around a perceived lack of clarity, and the regulation's overall scope and complexity – factors that have proven particularly challenging for companies with existing device on the European market. "Newel Health obtains EU MDR for blood pressure management platform" 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
09-06-2025
- Health
- Yahoo
Newel Health obtains EU MDR for blood pressure management platform
Amid the growing prevalence of hypertension in the EU, Italian health tech Newel Health has secured a CE mark for its Amicomed platform under the EU's Medical Device Regulation (EU MDR), enabling it to support the management of high blood pressure. Compatible with blood pressure monitors including Apple Health and Google Fit, the smartphone app-based platform captures structured blood pressure data and translates it into 'clinically meaningful' insights, Newel Health stated, and offers personalised feedback towards high blood pressure management based on real-world data. The platform's features include medication reminders to improve adherence, and personalised lifestyle and dietary recommendations based on a user's clinical profile. The capabilities are supported by Amicomed's architecture. Developed by Newel Health, the proprietary platform uses artificial intelligence (AI)-based predictive models to improve behavioural segmentation, sustain engagement, and adapt interventions based on an individual's profile. A 2023 report by GlobalData forecasts that AI platforms in healthcare will reach a valuation of $18.8bn by 2027. Newel Health CEO, Ervin Ukaj commented: "We designed Amicomed to offer a digital therapy that fits into people's everyday lives, supporting them, day by day, in managing hypertension. "The MDR certification confirms the strength of our platform and the reliability of our regulatory approach.' Ukaj added that Newel intends to pursue 'scalable growth' by seeking further partnerships with public and private healthcare stakeholders. Systemic hypertension is a key risk factor for chronic disease burden, and a known precursor for cardiovascular diseases (CVDs) including atherosclerotic cardiovascular disease, with research indicating that hypertension in the EU is on the rise. A European Commission (EC) survey from 2019 found that 22% of individuals aged 15 and above reported having received a high blood pressure diagnosis from a medical professional, while a 2023 report by the World Health Organization (WHO) estimates that the number of adults with hypertension in the European region and the Americas rose from 302 million in 1990 to 427 million in 2019 – reflecting a 41% rise. All medical device manufacturers marketing products in the EU must fall in line with the dictates of the EU MDR regulation by 2028. Introduced in 2017 and coming into its 'first phase' of effect in 2021, the EU MDR is promulgated as a means to centralise competencies at the EU level. While well-intentioned, some observers have deemed the regulation's roll out a 'disaster', with concerns around a perceived lack of clarity, and the regulation's overall scope and complexity – factors that have proven particularly challenging for companies with existing device on the European market. "Newel Health obtains EU MDR for blood pressure management platform" 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
16-05-2025
- Health
- Yahoo
Magstim Granted EU MDR Certification
Magstim TMS Granted EU MDR Certification Magstim Passes Compliance with Strict European Union Medical Device RegulationsExpanding Magstim Access to Entire EU Marketplace WHITLAND, United Kingdom, May 16, 2025 (GLOBE NEWSWIRE) -- Magstim has been granted EU MDR Certification for all transcranial magnetic stimulation (TMS) systems, demonstrating compliance with strict European Union Medical Device Regulations. This provides a path for Magstim TMS technology to be sold throughout the EU marketplace, and proves that the device is safe, clinically effective and has passed all requirements for testing and traceability. 'The EU MDR is the most rigorous certification backed by verified scientific knowledge,' said Ronnie Stolec-Campo, CEO, Welcony. 'As pioneers of neuromodulation for researchers and clinicians, our team is honoured to build world-class technology to study and treat the brain. This certification allows expanded reach to support this life-saving work.' The European Union Medical Device Regulation (EU MDR) governs the safety, performance, and quality of medical devices sold in the European Economic Area (EEA). It replaced the previous Medical Device Directive (MDD). The certification is issued by a Notified Body, an independent organization designated by an EU member state. 'Our customers can be confident that with this certification, Magstim technology has passed some of the most rigorous quality testing medical devices are subjected to,' said Stolec-Campo. 'The big thank you goes to our internal Welcony teams in Regulatory, R&D and support for your commitment to get this across the line—we know this will help people worldwide.' As the only integrated TMS technology, Magstim is now the only TMS system which can treat MDD, Anxious Depression, OCD, and Adolescent Depression with a single treatment coil. The FDA recently cleared the Magstim Horizon 3.0 and Inspire Transcranial Magnetic Stimulation Systems for treating adolescent patients aged 15-21 for MDD, providing a non-invasive, non-pharmacological technology to improve care. To learn more about the entire family of research and clinical neurotechnology innovations, visit or call 844-624-7846. About Welcony Globally, Welcony technologies have supported thousands of research labs, clinics, hospitals and universities that focus on mental health, brain disorders, cognitive neuroscience and neuromonitoring. Key brands include Magstim Magnetic Stimulation, MagstimEGI high-density EEG, Technomed Clinical Neurophysiology and Neurosign Interoperative Nerve Monitoring. Welcony is backed by Telegraph Hill Partners, a San Francisco based private equity company. Media Contact: Mark Sejvar, msejvar@ 323-363-3530 A photo accompanying this announcement is available at 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
