RCube Health, a digital therapeutics company, has announced that it has passed regulatory approvals to market its Anxiety app Resony in the UK.
The app is classified as UKCA software as a medical device (SaMD) by the Medicines and Healthcare Products Regulatory Agency (MHRA).
In addition, the Resony app has received ISO 13485 certification, an international standard for quality management systems for medical devices from the independent accreditation body NQA.
“We are thrilled to get these approvals,” said Ravi Janapureddy, RCube Health’s CEO.
“This marks our commitment to deliver safe and effective digital mental health solutions which are much needed now”.
The COVID-19 pandemic had a significant effect on the mental health of the population spurring the demand for therapy apps.
The searches for “anxiety” rose by 422 per cent alongside similar increases noted amongst other mental health conditions, as per Orcha, the digital health app formulary.
This has led to the “wild west of therapy apps” with technology coming to the aid of people with no access to regular mental healthcare.
But experts are concerned about this rapidly growing and unregulated market for apps putting users at the risk of downloading an unapproved, unrecommended and potentially unsafe app.
Digital therapeutic apps such as Resony bridge this barrier and can support healthcare authorities such as the NHS improve access to evidence-based mental health support.
RCube Health was recently awarded a grant as part of the Health Technology Regulatory and Innovation Programme, a joint initiative by Innovate UK, CPI and ABHI. This has helped them navigate the complex Healthtech regulatory processes.
Last year, the company was a finalist in the Bayer G4As Digital Health Partnerships Program and was recognised as a promising digital health innovator in the area of mental health.
They are being supported by MedCity, as part of a community pilot to help SMEs collaborate with NHS stakeholders, connect with investors and access commercialisation expertise.
RCube Health’s mission is to improve access to effective mental health support.
The company creates digital therapeutics, which are medical interventions delivered directly to users using clinically evaluated software.
The products are based on decades of clinical expertise and are designed in collaboration with clinicians, people and healthcare entrepreneurs.
RCube Health supports employers and NHS organisations in providing faster mental health and wellbeing support to their employees and people.
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