Latest news with #Amicomed
Yahoo
4 days ago
- 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
4 days ago
- 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
4 days ago
- Health
- Yahoo
Amicomed by Newel Health obtains EU MDR certification as a digital medical device for hypertension management
BASEL, Switzerland and MILAN, June 9, 2025 /PRNewswire/ -- Newel Health, a European HealthTech company specialized in certified digital medical devices, announced today that Amicomed, its solution for hypertension management, has received CE certification as a Class IIa medical device under the European Medical Device Regulation (MDR 2017/745). This milestone positions Amicomed among the leading candidate digital therapies poised to reshape hypertension management in Europe. Amicomed supports individuals in daily blood pressure self-management by offering personalized feedback based on real-world data and helping users between clinical visits. It captures structured blood pressure data and translates it into clinically meaningful insights for users and healthcare professionals. Key features include medication reminders to improve adherence and personalized lifestyle and dietary recommendations based on the user's clinical profile. In addition to its direct-to-consumer application, Amicomed can be deployed as a digital companion to antihypertensive therapies. It supports medication adherence and generates longitudinal behavioral insights. The solution has also been validated in population health programs for cardiovascular risk monitoring and chronic care optimization, as well as in digital insurance models focused on prevention and risk management. These use cases create pathways for adoption across pharmaceutical, insurance, and institutional ecosystems. "We designed Amicomed to offer a digital therapy that fits into people's everyday lives, supporting them, day by day, in managing hypertension," said Ervin Ukaj, CEO of Newel Health. "The MDR certification confirms the strength of our platform and the reliability of our regulatory approach, enabling us to bring Amicomed to millions of individuals across Europe and to pursue scalable growth in partnership with public and private healthcare stakeholders." Certified. Scalable. Integration-ready. Compatible with Apple Health, Google Fit, and major Bluetooth-enabled blood pressure monitors, Amicomed also accepts manual data entry, ensuring usability without connected devices. It provides users with weekly reports, personalized notifications, and structured summaries, while clinicians can monitor progress between visits. "Amicomed transformed available cardiovascular knowledge into a robust, intuitive digital solution designed for large-scale adoption," commented Professor Domenico Cianflone, member of the Scientific Advisory Board of Newel Health. Amicomed will be distributed through a multi-channel strategy that includes direct-to-consumer, health insurance partners, digital pharmacies, corporate wellness programs, and public healthcare systems. Strategic discussions and pilot programs are currently underway across several European countries. Powered by AI and personalization at the center Amicomed is built on Newel Health's proprietary platform that integrates clinical logic, behavioral science, and real-world data to deliver personalized digital therapeutic pathways. uses predictive models powered by artificial intelligence to improve behavioral segmentation, sustain engagement, and adapt interventions to the individual profile. The platform ensures clinical consistency, scalability, and alignment with international standards for safety, performance, and software quality. About Newel Health Newel Health is a European HealthTech company developing certified digital medical devices that combine clinical science, behavioral psychology, and intelligent technology. With teams in Milan, Basel, Salerno and Tallinn, the company creates software-based therapeutics that address chronic diseases where user behavior and real-world data are central to clinical outcomes. At Newel, user experience is part of the clinical model. Every solution is designed to be intuitive, engaging, and scalable. Through its proprietary platform Newel enables continuous product optimization informed by behavioral analytics and longitudinal health signals. Newel operates a full-stack infrastructure for the development, certification, and commercialization of software as a medical device across global markets, including the European Union, the United States, and China. The company works with pharmaceutical leaders, health insurers, and public health systems to co-develop and scale regulated therapeutics that are clinically validated, commercially viable, and globally deployable. Newel's portfolio includes certified therapeutics for hypertension (Amicomed) and chronic pain (Rohkea), with additional programs in Parkinson's disease, metabolic health, and cardiovascular prevention advancing through development. 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