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.
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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 H.Core 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.
