Digital Health FDA Cleared

Voluntis gets FDA nod for its Oleena cancer management product

French digital health company Voluntis recently received clearance by the FDA for its cancer management platform.

Dubbed Oleena, the company’s software acts as an aid for cancer patients by helping users self-manage their disease symptoms and allow for remote monitoring by clinicians through mobile and web technologies.

“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,” said Voluntis CEO Pierre Leurent in a statement.

Better managing symptoms, the theory goes, helps to improve overall health outcomes and decrease emergency hospitalizations and unplanned treatment interruptions.

The prescription-only digital therapeutic is intended to give patients contextually relevant and personalized recommendations on actions to help manage symptoms including guiding individuals in proper dosing and use of therapeutics. The company’s proprietary algorithms are customized according to a patient’s individual health situation and clinical care plan.

Oleena has been developed to work across a range of cancer types and anti-cancer treatments including chemotherapies, immunotherapies and targeted therapies. Among the symptoms managed by the tool are common issues associated with cancer like diarrhea, pain and nausea.

Data from a patient’s use of the system is then fed back to their clinical team who can use the information to adjust their care plan and gain additional clinical insights into the person’s condition.

“Digital therapeutics like Oleena represent a critically important addition to the management of symptoms at oncology practices level. The plain language and the user-friendly interfaces simplify the patient self-management,” Dr. Arvind Dasari, an oncologist at University of Texas MD Anderson Cancer Center in a statement.

“The embedded clinical algorithms enable automated and proactive intervention that aid health care teams, both in terms of personalization and standardization.”

Voluntis has developed other disease management tools, although Oleena is the company’s first FDA-cleared product in the oncology space. The company’s other digital therapeutics include Insulia and Diabeo, which helps patients better control their diabetes symptoms and guides users in their insulin dosage.


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