Anxiety app Resony receives regulatory approval in UK

Resony is one of a number of apps addressing the growing demand for digital support for mental health

25th August 2022 about a 2 minute read
“This marks our commitment to deliver safe and effective digital mental health solutions which are much needed now”. Ravi Janapureddy, CEO, Rcube Health

Resony, a mobile phone app for helping people with anxiety, has received regulatory approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

The app, which is marketed by digital therapeutics company RCube Health, has also received ISO 13485 certification, an international standard for quality management systems for medical devices. The MHRA accreditation means that the app now carries the UKCA mark, which is similar to the CE mark used in the EU.

RCube Health’s CEO, Ravi Janapureddy, said the company was “thrilled” to receive the approvals, adding: “This marks our commitment to deliver safe and effective digital mental health solutions, which are much needed now”.

The Covid-19 pandemic saw an increased demand from the public for therapeutic apps. A 2021 report from ORCHA, a digital health company, found that the number of people searching for mental health apps increased by 200% during lockdown.  In the past five years, the report shows, there has also been a very steep growth in the number of available apps to help people manage mental health conditions. The report found 3,857 in total.

Many of these apps, however, have not received regulatory approval, and there is concern that some may be unsafe. RCube Health says its apps are based on n decades of clinical expertise and are designed in collaboration with clinicians and healthcare entrepreneurs.

Techniques based on neuroscience

The techniques used in Resony, the company says, are created by an experienced medical team and are “based on neuroscience, positive psychology, behavioural science and physiology.” They include guided breathing exercises and progressive muscle relaxation to calm the body’s flight or fight response; journaling techniques to help users reframe negative experiences; and nature observation and active listening to address isolation and loneliness.

The company was recently awarded a grant as part of the Health Technology Regulatory and Innovation Programme, which has helped it navigate the complex route to regulatory approval. It is also supported by MedCity, the cluster organisation for the health and life sciences sector, as part of a community pilot to help SMEs collaborate with NHS stakeholders, connect with investors and access commercialisation expertise.

FCC Insight

As our own research shows, the pandemic saw a large rise in the number of people using digital tools for mental health support  – both because their mental health worsened and because it became harder to access face-to-face support. With such a large number of digital tools on the market, it can be difficult for users to know which are most effective. The regulator can play an important part in helping people identify which apps meet a particular threshold for safety and are fit for their intended purpose.