Voluntis Gets FDA Marketing Approval For Oleena Digital Therapeutic

Digital therapeutics provider Voluntis has secured market authorisation from the US Food and Drug Administration (FDA) for its Oleena software for oncology-related symptoms management and remote patient monitoring.

Claimed to be the first digital therapeutic in oncology, Oleena is an FDA class II software-as-a-medical device that can support patients across a wide range of cancer diagnoses and anticancer treatments.

The company has successfully completed a regulatory review of Oleena, which provides a digital approach with embedded clinical algorithms.

Oleena software-as-a-medical device

Oleena is a care companion for the cancer patient journey based on mobile and web technologies, which allows self-management of symptoms and remote monitoring by care teams.

The new digital therapeutic will guide patients and provide real-time and personalised recommendations on what to know and what to do, once it has been prescribed by a care team.

The recommendations comprise of personalised coaching for symptom management, in addition to on-demand directions for initiation and dosing of supportive therapies based on the patient’s individual care plan.

Healthcare teams secure access to automated and adaptative insights on their patient’s symptoms to support patients from anywhere.

Oleena enables to self-manage common side effects experienced by patients with cancer such as diarrhoea, pain and nausea.

Oleena, which is powered by a comprehensive set of algorithms, will support patients across a wide range of cancer diagnoses and anticancer treatments, including chemotherapies, immuno-therapies and targeted therapies such as PARP, PI3K, CDK4/6 inhibitors.

Oleena is supported by Theraxium Oncology, Voluntis’ platform involved in the development of digital therapeutics in the oncology space.

Oleena’s actionable insights and recommendations are offered based on the treatment plan set up by a patient’s care team and using evidence-based standards of symptom management and supportive care in US and EU consensus guidelines.

Voluntis CEO Pierre Leurent said: “Beyond monitoring their symptoms, we believe that empowering patients via the digital delivery of real-time and personalized therapeutic interventions offers the opportunity for significant clinical and economic outcomes.

“We are delighted to introduce Oleena, the first prescription digital therapeutic in oncology, to transform patients’ experience throughout their cancer journey.” – NS Medical Devices

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