Voluntis' symptom management platform for cancer patients receives FDA's blessing

Oleena's algorithms serve patients personalized guidance on how best to mitigate symptoms, while also monitoring and generating insights for their care team.
By Dave Muoio
03:30 pm

Paris, France-based Voluntis has received FDA marketing authorization for an algorithm-driven digital tool that helps cancer patients manage their symptoms and care teams identify clinical insights, the company announced last week.

The Oleena software is a Class II medical device that is prescribed by the patient’s care team. As the user logs their symptoms into the app, it adapts to offer personalized guidance on how each patient can self-manage their condition. These information range from symptom management coaching to instructions on how and when to take supportive therapies included in their care plan.

Meanwhile, the care team is provided with updates on the patient’s symptoms and how they are using the app, as well as with clinical insights identified by the tool.

“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,” Pierre Leurent, CEO of Voluntis, said in a statement. “We are delighted to introduce Oleena, the first prescription digital therapeutic in oncology, to transform patients’ experience throughout their cancer journey.”

Oleena is built upon Voluntis’ proprietary platform for digital oncology therapeutics, called Teraxium Oncology. It can be prescribed to patients undergoing a range of cancer types or treatments, with the latter including chemotherapies, immunotherapies and targeted therapies.


App-based tools like Oleena allow patients to not only take a more active role in their care, but also control severe symptoms that can complicate treatment. At the same time, its provider-facing component aims to improve patient monitoring and management through an interface that highlights the cases in need of more attention for clinician users — an approach that could mitigate the heavy burden many providers are facing.


While Oleena is unique in its positioning as a prescription-only tool, others have developed a variety of digital symptom management tools for cancer patients. Among these are Vine Health’s lifestyle and symptom tracking app, the chemoWave disease companion app and OncoLens’ provider-facing care coordination platform.

Voluntis, for its part, is best known for its existing digital tools for diabetes management. These include Insulia and Diabeo, both of which offer insulin dosing recommendations alongside remote monitoring and other features.


“Digital therapeutics like Oleena represent a critically important addition to the management of symptoms at oncology practices level,” Dr. Arvind Dasari of the University of Texas MD Anderson Cancer Center said in a statement provided by Voluntis. “The plain language and the user-friendly interfaces simplify the patient self-management. The embedded clinical algorithms enable automated and proactive intervention that aid health care teams, both in terms of personalization and standardization.”


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