Amicomed by Newel Well being obtains EU MDR certification as a digital medical machine for hypertension administration
Basel | Milan | June 9 – Newel Well being, a European HealthTech firm specialised in licensed digital medical gadgets, introduced at this time that Amicomed, its answer for hypertension administration, has obtained CE certification as a Class IIa medical machine underneath the European Medical Machine Regulation (MDR 2017/745). This milestone positions Amicomed among the many main candidate digital therapies poised to reshape hypertension administration in Europe.
Amicomed helps people in day by day blood strain self-management by providing personalised suggestions based mostly on real-world information and serving to customers between scientific visits. It captures structured blood strain information and interprets it into clinically significant insights for customers and healthcare professionals. Key options embody medicine reminders to enhance adherence and personalised way of life and dietary suggestions based mostly on the consumer’s scientific profile.
Along with its direct-to-consumer software, Amicomed will be deployed as a digital companion to antihypertensive therapies. It helps medicine adherence and generates longitudinal behavioral insights. The answer has additionally been validated in inhabitants well being applications for cardiovascular threat monitoring and persistent care optimization, in addition to in digital insurance coverage fashions targeted on prevention and threat administration. These use instances create pathways for adoption throughout pharmaceutical, insurance coverage, and institutional ecosystems.
We designed Amicomed to supply a digital remedy that matches into individuals’s on a regular basis lives, supporting them, daily, in managing hypertension,” mentioned Ervin Ukaj, CEO of Newel Well being. “The MDR certification confirms the power of our platform and the reliability of our regulatory strategy, enabling us to convey Amicomed to hundreds of thousands of people throughout Europe and to pursue scalable development in partnership with private and non-private healthcare stakeholders.
Licensed. Scalable. Integration-ready.
Suitable with Apple Well being, Google Match, and main Bluetooth-enabled blood strain screens, Amicomed additionally accepts handbook information entry, making certain usability with out related gadgets. It offers customers with weekly experiences, personalised notifications, and structured summaries, whereas clinicians can monitor progress between visits.
Amicomed remodeled obtainable cardiovascular data into a sturdy, intuitive digital answer designed for large-scale adoption,” commented Professor Domenico Cianflone, member of the Scientific Advisory Board of Newel Well being.
Amicomed will probably be distributed by a multi-channel technique that features direct-to-consumer, medical health insurance companions, digital pharmacies, company wellness applications, and public healthcare techniques. Strategic discussions and pilot applications are at the moment underway throughout a number of European international locations.
Powered by H.Core: AI and personalization on the heart
Amicomed is constructed on H.Core, Newel Well being’s proprietary platform that integrates scientific logic, behavioral science, and real-world information to ship personalised digital therapeutic pathways. H.Core makes use of predictive fashions powered by synthetic intelligence to enhance behavioral segmentation, maintain engagement, and adapt interventions to the person profile. The platform ensures scientific consistency, scalability, and alignment with worldwide requirements for security, efficiency, and software program high quality.
About Newel Well being
Newel Well being is a European HealthTech firm growing licensed digital medical gadgets that mix scientific science, behavioral psychology, and clever expertise. With groups in Milan, Basel, Salerno, and Tallinn, the corporate creates software-based therapeutics that handle persistent ailments the place consumer conduct and real-world information are central to scientific outcomes.
At Newel, consumer expertise is a part of the scientific mannequin. Each answer is designed to be intuitive, participating, and scalable. By means of its proprietary platform H.Core, Newel permits steady product optimization knowledgeable by behavioral analytics and longitudinal well being indicators.
Newel operates a full-stack infrastructure for the event, certification, and commercialization of software program as a medical machine throughout international markets, together with the European Union, america, and China. The corporate works with pharmaceutical leaders, well being insurers, and public well being techniques to co-develop and scale regulated therapeutics which might be clinically validated, commercially viable, and globally deployable.
Newel’s portfolio contains licensed therapeutics for hypertension (Amicomed) and persistent ache (Rohkea), with extra applications in Parkinson’s illness, metabolic well being, and cardiovascular prevention advancing by improvement.
For extra info: www.newel.well being
Media contact: media@newel.well being
Amicomed by Newel Well being obtains EU MDR certification as a digital medical machine for hypertension administration
Basel | Milan | June 9 – Newel Well being, a European HealthTech firm specialised in licensed digital medical gadgets, introduced at this time that Amicomed, its answer for hypertension administration, has obtained CE certification as a Class IIa medical machine underneath the European Medical Machine Regulation (MDR 2017/745). This milestone positions Amicomed among the many main candidate digital therapies poised to reshape hypertension administration in Europe.
Amicomed helps people in day by day blood strain self-management by providing personalised suggestions based mostly on real-world information and serving to customers between scientific visits. It captures structured blood strain information and interprets it into clinically significant insights for customers and healthcare professionals. Key options embody medicine reminders to enhance adherence and personalised way of life and dietary suggestions based mostly on the consumer’s scientific profile.
Along with its direct-to-consumer software, Amicomed will be deployed as a digital companion to antihypertensive therapies. It helps medicine adherence and generates longitudinal behavioral insights. The answer has additionally been validated in inhabitants well being applications for cardiovascular threat monitoring and persistent care optimization, in addition to in digital insurance coverage fashions targeted on prevention and threat administration. These use instances create pathways for adoption throughout pharmaceutical, insurance coverage, and institutional ecosystems.
We designed Amicomed to supply a digital remedy that matches into individuals’s on a regular basis lives, supporting them, daily, in managing hypertension,” mentioned Ervin Ukaj, CEO of Newel Well being. “The MDR certification confirms the power of our platform and the reliability of our regulatory strategy, enabling us to convey Amicomed to hundreds of thousands of people throughout Europe and to pursue scalable development in partnership with private and non-private healthcare stakeholders.
Licensed. Scalable. Integration-ready.
Suitable with Apple Well being, Google Match, and main Bluetooth-enabled blood strain screens, Amicomed additionally accepts handbook information entry, making certain usability with out related gadgets. It offers customers with weekly experiences, personalised notifications, and structured summaries, whereas clinicians can monitor progress between visits.
Amicomed remodeled obtainable cardiovascular data into a sturdy, intuitive digital answer designed for large-scale adoption,” commented Professor Domenico Cianflone, member of the Scientific Advisory Board of Newel Well being.
Amicomed will probably be distributed by a multi-channel technique that features direct-to-consumer, medical health insurance companions, digital pharmacies, company wellness applications, and public healthcare techniques. Strategic discussions and pilot applications are at the moment underway throughout a number of European international locations.
Powered by H.Core: AI and personalization on the heart
Amicomed is constructed on H.Core, Newel Well being’s proprietary platform that integrates scientific logic, behavioral science, and real-world information to ship personalised digital therapeutic pathways. H.Core makes use of predictive fashions powered by synthetic intelligence to enhance behavioral segmentation, maintain engagement, and adapt interventions to the person profile. The platform ensures scientific consistency, scalability, and alignment with worldwide requirements for security, efficiency, and software program high quality.
About Newel Well being
Newel Well being is a European HealthTech firm growing licensed digital medical gadgets that mix scientific science, behavioral psychology, and clever expertise. With groups in Milan, Basel, Salerno, and Tallinn, the corporate creates software-based therapeutics that handle persistent ailments the place consumer conduct and real-world information are central to scientific outcomes.
At Newel, consumer expertise is a part of the scientific mannequin. Each answer is designed to be intuitive, participating, and scalable. By means of its proprietary platform H.Core, Newel permits steady product optimization knowledgeable by behavioral analytics and longitudinal well being indicators.
Newel operates a full-stack infrastructure for the event, certification, and commercialization of software program as a medical machine throughout international markets, together with the European Union, america, and China. The corporate works with pharmaceutical leaders, well being insurers, and public well being techniques to co-develop and scale regulated therapeutics which might be clinically validated, commercially viable, and globally deployable.
Newel’s portfolio contains licensed therapeutics for hypertension (Amicomed) and persistent ache (Rohkea), with extra applications in Parkinson’s illness, metabolic well being, and cardiovascular prevention advancing by improvement.
For extra info: www.newel.well being
Media contact: media@newel.well being
